Battery Event: Premature Discharge of Battery

BOSTON SCIENTIFIC CORPORATION PROPONENT MRI EL DR IMPLANTABLE PACEMAKERBack to Search Results

Model Number L231

Device Problem Premature Discharge of Battery (1057)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2020

Event Type  Injury  

 

Event Description

It was reported that the battery of this implantable pacemaker was suspected to be depleting prematurely. A request was made to have data from this device analyzed. Data analysis confirmed the battery appeared to be depleting more quickly than expected. Device replacement was recommended, however this pacemaker remains in-service at this time. Additional information was received. This pacemaker was explanted and returned to boston scientific for analysis. No additional adverse patient effects were reported.

Have somebody experience with this problem?

I‘ve had my proponent 1 year (get it 5/22) and the expected battery time is 8,5 years now.

The event date in the message is 11.4.20! 

Best regards and a long life battery

for pace and peace

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=12251318&pc=LWP

https://www.bfarm.de/SharedDocs/Kundeninfos/EN/01/2018/11557-18_kundeninfo_en.pdf?__blob=publicationFile&v=1


3 Comments

Premature battery depletion

by AgentX86 - 2023-08-16 01:26:10

Pacemaker "recalls" aren't all that rare.  I've never heard of any that were still in service actually being replaced.  It's more dangerous to replace every affected pacemaker than to watch for failure of individual unitse.

Mine (Medtronic) is also under recall with a warning to watch for premature failure.  It's monitored at each remote interrogation and set to call home immediately if it goes into ERI. Since I am dependent, at ERI replacement is to be treated as an emergency.  The problem is a faulty capacitor that can fail, draining the battery quickly.  It's a very rare occurance but would be a very bad thing.

 

bad thing

by The Right Pace Make Peace - 2023-08-16 04:37:25

How long you have your PM and what is your expected battery time now?

Boston told 2021: "There are no longer any of the affected systems for implantation on the market."

1 Year later I've had my implantation.

longer any of the affected systems

by AgentX86 - 2023-08-16 16:08:57

This means that the problem has been corrected as of that date and any pacemakers implanted after are not affected. If you want to dig deeper, there is probably a range of serial numbers affected on the web somewhere.  If you can find it, compare it with yours.

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