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

Model Number	L201
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information was requested.The investigation will be updated should further information be provided.
Event or Problem Description
It was reported that the battery of this implantable device was suspected to be depleting prematurely.This device remains in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that the battery of this implantable device was suspected to be depleting prematurely.This device was replaced and returned for analysis.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Supplemental: the product has been received for analysis.This report will be updated upon completion of analysis.Initial: additional information was requested.The investigation will be updated should further information be provided.
Event or Problem Description
It was reported that the battery of this implantable device was suspected to be depleting prematurely.This device was replaced and returned for analysis.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Supplemental 2: the product was returned and analyzed.The pulse generator case was removed for the analysis.The battery voltage was lower than expected, but still supported full device function.An electrical leakage was confirmed as a result of a high current drain caused by leaky ceramic battery bypass capacitor, due to a crack in the ceramic capacitor.The behavior of these capacitors resulted in a high current drain, which was depleting the device battery faster than normal.Supplemental: the product has been received for analysis.This report will be updated upon completion of analysis.Initial: additional information was requested.The investigation will be updated should further information be provided.

• Brand Name: PROPONENT DR
• Common Device Name: 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 Key: 11228629
• Report Number: 2124215-2021-01740
• Device Sequence Number: 19725502
• Product Code: LWP
• UDI-Device Identifier: 00802526559044
• UDI-Public: 00802526559044
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: N970003/S167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/04/2021
• Device Model Number: L201
• Device Catalogue Number: L201
• Device Lot Number: 781360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 11/18/2021; 06/21/2022
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 01/19/2022; 07/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female