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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PROPONENT MRI EL DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

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BOSTON SCIENTIFIC CORPORATION PROPONENT MRI EL DR; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) Back to Search Results
Model Number L231
Device Problems Premature Discharge of Battery (1057); Battery Problem (2885)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/12/2024
Event Type  malfunction  
Event Description
It was reported that this implantable pacemaker's battery was found to be depleting faster than expected.The physician suspected that the battery was exhibiting premature depletion.A surgical replacement procedure was scheduled for the end of april to resolve the event.At this time, the device remains implanted and in-service.No adverse patient effects were reported.
 
Event Description
It was reported that this implantable pacemaker's battery was found to be depleting faster than expected.The physician suspected that the battery was exhibiting premature depletion.Recently, this device had entered safety mode and was explanted and replaced to resolve the event.No additional adverse patient effects were reported.This pacemaker is expected to be returned for analysis, but has not yet been received.
 
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Brand Name
PROPONENT MRI EL DR
Type of Device
IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
cashel road
clonmel
EI  
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key19218347
MDR Text Key341466136
Report Number2124215-2024-26368
Device Sequence Number1
Product Code LWP
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
P150012/S000
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 04/30/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date06/08/2018
Device Model NumberL231
Device Catalogue NumberL231
Device Lot Number720718
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/12/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/24/2016
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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