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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 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, as noted during a routine follow-up.Six months prior, the battery was at 5.5 years of remaining life however, at the most recent check up, the remaining life had dropped to three years.The physician stated no intervention at this time and plans to monitor every six months.No resulting adverse patient effects have been reported.

• 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
• MDR Report Key: 12114079
• Report Number: 2124215-2021-17916
• Device Sequence Number: 14640439
• Product Code: LWP
• UDI-Device Identifier: 00802526559044
• UDI-Public: 00802526559044
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: N970003/S167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/26/2018
• Device Model Number: L201
• Device Catalogue Number: L201
• Device Lot Number: 746320
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2021
• Initial Report FDA Received Date: 07/03/2021
• Patient Sequence Number: 1
• Patient Age: 79 YR