MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCOLADE DR; PACEMAKER

Model Number L301

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2022

Event Type  malfunction  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.A high current drain was detected, but the battery still supported full device function.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 issued a field safety notice regarding a subset of devices in the accolade pacemaker family that have a potential of exhibiting this behavior.This particular device is included in the hydrogen induced premature depletion advisory population.

Event Description

It was reported that this pacemaker was explanted without allegations from the field.It was subsequently returned for analysis.No adverse patient effects were reported.

• Brand Name: ACCOLADE DR
• Type of Device: PACEMAKER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16043494
• MDR Text Key: 308004922
• Report Number: 2124215-2022-54812
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N970003/S167
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 12/23/2022

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
• Device Operator: Other
• Device Expiration Date: 05/11/2017
• Device Model Number: L301
• Device Catalogue Number: L301
• Device Lot Number: 708638
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2022
• Initial Date Manufacturer Received: 12/20/2022
• Initial Date FDA Received: 12/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male