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

Model Number	L201
Medical Device Problem Codes	Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	01/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient implanted with this pacemaker experienced a syncopal event.When the device was checked, a red warning screen was displayed on the programmer, indicating the device had reverted to safety mode operation.The device had only been implanted for about four years; premature battery depletion was suspected, and the device was not able to be reprogrammed.The patient was admitted to the hospital as pauses in pacing were observed on the electrocardiogram.The device was explanted and replaced the following day.No additional adverse patient effects were reported.The explanted device was expected to be returned for analysis.
Additional Manufacturer Narrative
The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.
Additional Manufacturer Narrative
The product is expected to be returned for analysis.This report will be updated upon return and completion of analysis.Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety mode and that bradycardia therapy remained available.Detailed review of the device memory found multiple areas were corrupted.Engineers determined that this device was demonstrating behavior consistent with a high internal cell impedance within the battery.The high internal impedance put this device at risk of experiencing transient voltage decreases (and associated resets) during periods of high-power consumption.When battery voltage drops below a minimum threshold, a system reset is performed.If three system resets occur within a 48-hour period, the device is designed to immediately enter safety mode operation to maintain back-up pacing with pre-defined, non-programmable settings.
Event or Problem Description
It was reported that the patient implanted with this pacemaker experienced a syncopal event.When the device was checked, a red warning screen was displayed on the programmer, indicating the device had reverted to safety mode operation.The device had only been implanted for about four years; premature battery depletion was suspected, and the device was not able to be reprogrammed.The patient was admitted to the hospital as pauses in pacing were observed on the electrocardiogram.The device was explanted and replaced the following day.No additional adverse patient effects were reported.The explanted device was expected to be returned for analysis.

• 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: 16253486
• Report Number: 2124215-2023-03341
• Device Sequence Number: 12130771
• Product Code: LWP
• UDI-Device Identifier: 00802526559044
• UDI-Public: 00802526559044
• Combination Product (Y/N): N
• Initial Reporter Country: EC
• PMA/510(K) Number: N970003/S167
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2023

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: 05/03/2018
• Device Model Number: L201
• Device Catalogue Number: L201
• Device Lot Number: 743329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 01/27/2023
• Supplement Report FDA Received Date: 07/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2016
• 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: 81 YR
• Patient Sex: Female