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

Model Number	L221
Medical Device Problem Codes	Signal Artifact/Noise (1036); Premature Discharge of Battery (1057); Over-Sensing (1438)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	06/19/2020
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 received.
Event or Problem Description
It was reported that this pacemaker showed a remaining longevity of three years.Premature battery depletion was suspected and device data was submitted to technical services for evaluation.Upon review, it was confirmed the device was exhibiting an increase in power consumption and device replacement was recommended for within 90 days.Technical services also noted there was oversensing of noise on the right atrial (ra) channel.No adverse patient effects were reported.The device remains implanted and in service.
Event or Problem Description
It was reported that this pacemaker showed a remaining longevity of three years.Premature battery depletion was suspected and device data was submitted to technical services for evaluation.Upon review, it was confirmed the device was exhibiting an increase in power consumption and device replacement was recommended for within 90 days.Technical services also noted there was oversensing of noise on the right atrial (ra) channel.No adverse patient effects were reported.The device remains implanted and in service.The field representative confirmed the replacement procedure was scheduled for august 3.An insulation fracture was suspected in the ra lead and the physician intended to replace the lead at the device change out procedure.The device was explanted, replaced, and returned for laboratory analysis.No additional adverse patient effects were reported.However, during the procedure, the physician opted to keep the ra lead and it remains implanted and in service with the new device.
Additional Manufacturer Narrative
The device remains implanted and in service.This report will be updated when additional information is received.Patient code 3191 captures the reportable event of surgery.Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.A high current drain was detected.Detailed analysis confirmed the identified high current drain was a result of compromised capacitors.This resulted in the observed premature battery depletion.It was determined that the capacitors were compromised due to the presence of excess hydrogen in the device case.Boston scientific has issued an advisory communication regarding a subset of pacemakers in the accolade product family that has an elevated potential of exhibiting this behavior.This particular device was not included in the hydrogen induced premature depletion advisory population.However, this capacitor behavior can still occur in non-advisory devices.

• 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: 10306128
• Report Number: 2124215-2020-15058
• Device Sequence Number: 3416935
• Product Code: LWP
• UDI-Device Identifier: 00802526559112
• UDI-Public: 00802526559112
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 10/21/2020

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: 09/14/2017
• Device Model Number: L221
• Device Catalogue Number: L221
• Device Lot Number: 705172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Initial Date Received by Manufacturer: 06/22/2020
• Supplement Date Received by Manufacturer: 08/03/2020
• Initial Report FDA Received Date: 07/21/2020
• Supplement Report FDA Received Date: 10/21/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 49 YR