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

Model Number L301

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Battery Problem (2885)

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

Event Date 03/05/2024

Event Type  Injury  

Event Description

It was reported that the patient with this pacemaker device was found in safety mode.Technical services (ts) stated that the patient was 31% right ventricular (rv) paced and the battery longevity was showing at 1.5 years remaining and depleting early than expected.This device currently remains in service.No adverse patient effects were reported.

Event Description

It was reported that the patient with this pacemaker device was found in safety mode.Technical services (ts) stated that the patient was 31% right ventricular (rv) paced and the battery longevity was showing at 1.5 years remaining and depleting early than expected.This device currently remains in service.No adverse patient effects were reported.Additional information received indicated that this device was explanted and successfully replaced.No additional patient adverse effects were reported.

Manufacturer Narrative

This report captures additional information of the explant of this device and impact on the patient.

• Brand Name: ACCOLADE DR
• Type of Device: PACEMAKERS
• 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: 18932330
• MDR Text Key: 338341353
• Report Number: 2124215-2024-16487
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/25/2018
• Device Model Number: L301
• Device Catalogue Number: L301
• Device Lot Number: 735068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/19/2024
• Supplement Dates Manufacturer Received: 03/27/2024
• Supplement Dates FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2016
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 97 YR
• Patient Sex: Male