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	12/06/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the battery of this pacemaker was suspected to be prematurely depleting.It was also reported that the patient's associated lead was not working, however we have no information on the model and/or serial combination of this product.At this time, no intervention has been performed and the pacemaker remains in service.No adverse patient effects were 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
• 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: 15977618
• Report Number: 2124215-2022-52628
• Device Sequence Number: 6922237
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/14/2022

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: 04/04/2021
• Device Model Number: L201
• Device Catalogue Number: L201
• Device Lot Number: 781402
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 12/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/21/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown