MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACCOLADE DR; IMPLANTABLE DEVICE

Model Number L301

Device Problem Battery Problem (2885)

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

Event Date 03/12/2024

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this pacemaker device had less than three months battery longevity remaining and now at four months.Boston scientific technical services (ts) explained that there was quite a variation in the right ventricular (rv) output, and it was also higher.Ts discussed that the higher output and larger swings with each test, changes in time remaining are being seen.This device remains in service.No adverse patient effects were reported.

• Brand Name: ACCOLADE DR
• Type of Device: IMPLANTABLE DEVICE
• 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: 19013334
• MDR Text Key: 339036545
• Report Number: 2124215-2024-19444
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559174
• UDI-Public: 00802526559174
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/01/2024

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: Lay User/Patient
• Device Expiration Date: 12/21/2018
• Device Model Number: L301
• Device Catalogue Number: L301
• Device Lot Number: 754565
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2017
• 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: 84 YR
• Patient Sex: Female