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

Model Number	L221
Medical Device Problem Code	Premature Discharge of Battery (1057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device remains implanted.Should additional information become available this investigation will be updated.
Event or Problem Description
It was reported that a request for data review was needed due to a decrease in the battery of this device from eight years to five and a half years at the nine month follow up interval.A review of the device data by technical services (ts) confirmed that the device was exhibiting moderate acceleration in the rate of battery depletion.Ts confirmed the power consumption was increasing during the past year and was expected to confirm to increase.The device should be explanted and replaced.Ts also noted that assuming the device behavior remains unchanged there was sufficient battery capacity to support therapy and replacement for at least ninety days.The device remains implanted.No adverse patient effects were reported.
Additional Manufacturer Narrative
This device will be returned for analysis.Upon analysis completion this investigation will be updated.
Event or Problem Description
It was reported that a request for data review was needed due to a decrease in the battery of this device from eight years to five and a half years at the nine month follow up interval.A review of the device data by technical services (ts) confirmed that the device was exhibiting moderate acceleration in the rate of battery depletion.Ts confirmed the power consumption was increasing during the past year and was expected to confirm to increase.The device should be explanted and replaced.Ts also noted that assuming the device behavior remains unchanged there was sufficient battery capacity to support therapy and replacement for at least ninety days.The device was explanted and will be returned.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that a request for data review was needed due to a decrease in the battery of this device from eight years to five and a half years at the nine month follow up interval.A review of the device data by technical services (ts) confirmed that the device was exhibiting moderate acceleration in the rate of battery depletion.Ts confirmed the power consumption was increasing during the past year and was expected to confirm to increase.The device should be explanted and replaced.Ts also noted that assuming the device behavior remains unchanged there was sufficient battery capacity to support therapy and replacement for at least ninety days.The device was explanted and returned.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.A high current drain was detected, but the battery still supported full device function.Detailed analysis confirmed the identified high current drain was a result of compromised capacitors.This resulted in the observed premature battery depletion.It was determined that the capacitors were compromised due to the presence of excess hydrogen in the device case.

• Brand Name: PROPONENT EL 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: 12644365
• Report Number: 2124215-2021-27485
• Device Sequence Number: 16429075
• Product Code: LWP
• UDI-Device Identifier: 00802526559112
• UDI-Public: 00802526559112
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2022

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: 10/15/2016
• Device Model Number: L221
• Device Catalogue Number: L221
• Device Lot Number: 100211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2021
• Supplement Date Received by Manufacturer: 10/27/2021; 02/10/2022
• Initial Report FDA Received Date: 10/17/2021
• Supplement Report FDA Received Date: 01/06/2022; 04/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male