I work in med/surg/trauma ICU at an inner city level ! trauma hospital. I had a pt. the other day that came in from a cardiac event and required the hypothermia protocol.
He was 58 and living in an ECF when his ICD fired off 77 times non warranted due to a recalled fractured lead. According to the interrogation of his ICD his heart was never in a shockable rhythm. I'm assuming that the shocks caused an S on T rhythm or an ischemic event throwing the heart into asystole.
This patient was warmed back up and ran through the brain death protocol and finally pulled off the vent and pronounced yesterday.
My dilemma is that the family does not know about the fractured lead in his ICD and that's what ultimately killed him. Obviously this could cost the company millions of dollars and bad business fro the hospital so I was instructed by the cardiologist and upper management to not disclose this information to the family. However I know if it were my father lying dead on that hospital bed I would sure want to know the truth.
I agree with others, report it to the ethics committee. They will reconcile the situation with your facility's "mission statement" and policies, as well as state and feceral regulations. Protecting the maker of the device doesn't even enter the equation.
The fractured leads have been happening with Medtronic AICDs. They have issued a recall and patients with these leads are told of the "recall" and brought in for more frequent device interrogations to try and avert what you described. I've had a few patients who were lucky enough to come in as soon as their devices started acting up and their leads were quickly replaced. We even have a local malpractice attorney advertising on television for client with Medtronic ICDs and fractured leads.
I had a similar case in where an elderly woman had renal insufficiency and an outlying hospital MD had placed bilateral renal artery stents. She had greatly improved renal function after the arteries had been opened and even felt in better health. However, the docs there didn't even put her on any kind of anticoagulant therapy, much less plavix or a daily aspirin. She completely thrombosed both renal artery stents and wound up with infarcted kidneys and on chronic dialysis.
Specializes in ICU, ER (ED), CCU, PCU, CVICU, CCL.
This is acutally a fairly "common" event with a certian lead. Or should I say becoming a more common event. Of the major manufacturers of devices, all but one have had lead or device recalls in the past few years. One never had had a recall at all. This particular lead has an issue with where is is "wielded" and is subject to fracture. We have been replacing them frequently in my cath lab and I have heard of 4-5 other stories just like your in the past 3 months. However there are other factors to consider:
1. The patient has a device because they are high risk for sudden death.It is not know if the lead is fractured until it is removed. However the rep knows by looking at the interagator if the impeadance is too low that the lead is most likely fractured.
2. You obligation was to render care and suppport which you did. Your not an expert on devices or lead fractures or on recalls.
3. It's a sentenal event for the device manufacturer and they are aware of it. They tell us in the labs (mostly the compatition) about whos leads are on recall and what devices are having issues
4. You have an ethics committee. Report to them. Say nothing to anyone not related to this case, ansewer no questions by the family or attorney without your risk management team being aware of what is going on.
What is your hospital's policy on telling the family information? You need to look it up and follow it to the letter. The family is grieving, they are going to hear what they want to hear. If you tell them what you think, then they are going to say, his nurse told us that the fractured lead killed him. You are going to have to go to court if it goes to court. Your hospital will not have your back, because you are only covered by them when you are following their policies. You are going to be on the witness stand and questioned harshly about when you became an expert on these leads. It will get ugly, you will be looking for a job.
Go to the ethics commitee. The family knows what ICD he had and may be aware of the recall. I might not tell the ethics commitee what the cardiologist and upper management said to you. I'll go out on a limb and say that if they want to cover this to the family that they will have no problem saying that you are lying and they never said such a thing. It is much easier to replace a staff nurse than a cardiologist and upper management. Once the ethics commitee is involved this has to go somewhere, they can't sit on it.
Doesn't JCHAO have an anonymous whistle blower line?
Of course it is easy for me to say all of this, because I am not personally involved. I can say I would be losing sleep over this if it happened to me. You sound like a wonderful nurse, and I commend you for your desire to do the right thing.
I might even look for another job, not sure I could work for people like this.
Sorry if it sounds like I have ADD, I just keep thinking of more stuff.
Well I did tell the family that his heart never went into a shockable rhythm according to the interrogation; that's why they think it didn't fire.
I'm getting the impression that you've already communicated more than you or your hospital would have required. If the profile of your years of experience is accurate, then you could chalk it up to inexperience. If you are concerned about repercussions, then this thread is an attempt at validating your actions and confirming that you did "the right thing".
This post isn't intended to be harsh or judgey... it's just that it's easier for others to help you if they understand your full motivation for starting the thread.
Are you concerned that you've communicated too much? Is your hospital/team aware of your communication to the family? What did they say or what did you hear?
Specializes in ICU, ER (ED), CCU, PCU, CVICU, CCL.
i'll post this link to a wsj artilce on the lead. we don't "explant" the leads often as the risk of myocardial wall rupture is higher than the risk of leaving a lean in place. we no longer use this lead. i don't know if it was medtronic... but i'll go out on a limb and say it was.
btw the only pacemaker manufacture that has never had a recall issued is biotronic.... since 1964! many company "cross manufacture" devices and leads for eachother, so there is a lot of finger pointing. bs (boston scientific) might get a lead made by st. jude and call it something else (psssst... it's stamped on the lead who made it). i don't represent any company. well put them all in... and take them all out!
in a worrisome development for hundreds of thousands of heart patients, medtronic is suspending sales of a family of wires that connect implantable cardiac devices to the heart, because the wires may break inside the patient.
the wires, which doctors call leads, are sold under the name sprint fidelis and may have contributed to five deaths, the company [color=#0253b7]said.
for most patients, medtronic and its advisers have determined that removing the leads would be riskier than leaving them in. in [color=#0253b7]this letter to doctors, the company advises keeping the lead in place and reprogramming the defibrillator to minimize the risks of trouble.
{snip}
the company estimates that 2.3% of the sprint fidelis leads may fracture within 30 months of being implanted, compared with a 0.9% rate for the company’s sprint quattro. in the company’s analysis, that difference isn’t statistically significant but would become significant over time if current trends continue.
when a lead fractures, it can cause the device to deliver a powerful, unnecessary shock to the patient. it may also cause the device’s battery to run down prematurely. because leads are threaded through a vein toward the heart, and tend to have scar tissue build up around them, removing a lead can be a dangerous procedure.
Device failures (such as the AICD) should be reported to the FDA. The hospital is required to report these. The FDA keeps statistics on this for possible device recalls.
TLCinCICU
66 Posts
I agree with others, report it to the ethics committee. They will reconcile the situation with your facility's "mission statement" and policies, as well as state and feceral regulations. Protecting the maker of the device doesn't even enter the equation.
The fractured leads have been happening with Medtronic AICDs. They have issued a recall and patients with these leads are told of the "recall" and brought in for more frequent device interrogations to try and avert what you described. I've had a few patients who were lucky enough to come in as soon as their devices started acting up and their leads were quickly replaced. We even have a local malpractice attorney advertising on television for client with Medtronic ICDs and fractured leads.
I had a similar case in where an elderly woman had renal insufficiency and an outlying hospital MD had placed bilateral renal artery stents. She had greatly improved renal function after the arteries had been opened and even felt in better health. However, the docs there didn't even put her on any kind of anticoagulant therapy, much less plavix or a daily aspirin. She completely thrombosed both renal artery stents and wound up with infarcted kidneys and on chronic dialysis.