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 Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	06/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted and in service.This report will be updated when additional information is available.
Event or Problem Description
It was reported that during a routine device follow-up, the remaining longevity on this pacemaker was less than expected.At the previous device check in (b)(6) 2020 the remaining longevity was 5 years and currently it was 3.5 years.Premature battery depletion was suspected and the physician intended to replace the device.No adverse patient effects were reported.The device remains implanted and in service pending a replacement procedure.
Additional Manufacturer Narrative
The device remains implanted and in service.This report will be updated when additional information is available.Patient code 3191 captures the reportable event of surgery.This device has not been returned; therefore, technical analysis cannot be conducted.Without a returned device it is not possible to definitively confirm how the device may have contributed to the complaint incident.
Event or Problem Description
It was reported that during a routine device follow-up, the remaining longevity on this pacemaker was less than expected.At the previous device check in march 2020 the remaining longevity was 5 years and currently it was 3.5 years.Premature battery depletion was suspected and the physician intended to replace the device.No adverse patient effects were reported.The device remains implanted and in service pending a replacement procedure.The local field representative later reported that the patient was implanted with a new device in the city of (b)(6).No further details were able to be obtained.The explanted device was not returned for laboratory analysis.

• 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
• MDR Report Key: 10299645
• Report Number: 2124215-2020-14749
• Device Sequence Number: 2978672
• Product Code: LWP
• UDI-Device Identifier: 00802526559112
• UDI-Public: 00802526559112
• 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: 2016
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2021

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: 12/04/2017
• Device Model Number: L221
• Device Catalogue Number: L221
• Device Lot Number: 708570
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2020
• Supplement Date Received by Manufacturer: 10/23/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 01/06/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR