FDA notice on Medtronic pacemakers

https://www.fda.gov/medical-devices/safety-communications/fda-alerts-providers-and-patients-check-premature-battery-depletion-certain-medtronic-pacemakers-fda


6 Comments

battery depletion

by ROBO Pop - 2019-05-08 12:49:07

Medtronics didn't want to be outdone by St. Judes (Abbott) so they copied this feature. They'll just monitor more closely

battery depletiom

by fox30 - 2019-05-08 17:55:37

from the website TCTMD 

Three cases of premature battery depletion in Medtronic PMs including one death/ Five  products lines  were identified;Azure,Astra, Percepta, Serena and Solara.(I don't t understand how six product lines were implicated in 3 cases). Problem said to be due to a cracked capacitor and the premature battery failure occured within 7 months of implantation. 

Medscape may 7 2019 describes "two dozen pacemaker models" under 5  products lines (those mentioned above)The alert cover 132000 PMS and CRT-P units. 

These cases involved a fully drained PM because of a capacitor crack and occured  "without warning to the patient or healthcare provider"

The FDA alert was issued May 7 2019.

 

 

 

 

six product lines were implicated in 3 cases

by AgentX86 - 2019-05-09 18:51:44

They all use the faulty capacitors. Not good - mine is a Percepta Quad (W4TR01).

Battery depletion

by IPGENG12 - 2019-05-09 18:58:06

I was actually surprised to see that FDA/Medtronic published an alert on this.   The published failure rate at 0.0028% is quite low and the guidance to patients with the devices to seek immediate medical care if you get out of breath, dizzy, pass out is exactly the same for any pacemaker or ICD patient.  This is what I was told when I got my device in 2015, so I'm not sure the alert is that helpful.  The rule is "if you start feeling bad, get help quickly" with these systems.

The alert did say that Medtronic had deployed a new manufacturing step to help catch these cracked ceramic capacitors on newly made units.  If anyone out there has some details on that, I would certainly be interested in how they do that.

Seek immediate medical attention

by AgentX86 - 2019-05-09 22:01:30

You bet! But it sounds like the failure is very quick.  I don't believe Medtronics have audible alarms, so it might not be noticed until the pacemaker was non-functional.  That would be good for those of us who are dependent. Paranoia strikes deep. Into your life it will creep.

battery depletion

by fox30 - 2019-05-10 09:55:14

I believe the Medtronic PMs do not have audible alarms but the ICDs may.

Again call Medtronic patient services and ask ( 1 800 551 544) they h ave been helpful when I have called and they answered their phone, better than the voice mail I get when I call my hospital based PM center. 

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