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	02/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this device was suspected of exhibiting premature battery depletion behavior.A decrease in the estimated battery longevity was observed between follow-up visits.The most recent estimated battery longevity is showing 3.5 years remaining.This device currently remains implanted and in service.No adverse patient effects were reported.
Event or Problem Description
It was reported that this device was suspected of exhibiting premature battery depletion behavior.A decrease in the estimated battery longevity was observed between follow-up visits.The most recent estimated battery longevity is showing 3.5 years remaining.This device currently remains implanted and in service.No adverse patient effects were reported.Additional information: new information was provided which indicates that this device was explanted and replaced.No additional adverse patient effects were reported.This device is expected for return.
Additional Manufacturer Narrative
Should additional information become available, a supplemental report will be provided.
Event or Problem Description
It was reported that this device was suspected of exhibiting premature battery depletion behavior.A decrease in the estimated battery longevity was observed between follow-up visits.The most recent estimated battery longevity is showing 3.5 years remaining.This device currently remains implanted and in service.No adverse patient effects were reported.Additional information: further information was provided from the field representative indicating that this device still remains implanted, and that the patient has not yet had a follow-up visit since the premature battery depletion was observed.Should additional information become available, a supplemental report will be provided.

• 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: 16386108
• Report Number: 2124215-2023-07101
• Device Sequence Number: 5515068
• Product Code: LWP
• UDI-Device Identifier: 00802526559112
• UDI-Public: 00802526559112
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: N970003/S167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/22/2024

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: 10/28/2019
• Device Model Number: L221
• Device Catalogue Number: L221
• Device Lot Number: 723061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 07/30/2023; 02/06/2024
• Initial Report FDA Received Date: 02/16/2023
• Supplement Report FDA Received Date: 08/22/2023; 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown