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

Model Number L300

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate or Unexpected Reset (2959)

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

Event Date 03/21/2023

Event Type  malfunction  

Event Description

It was reported that this pacemaker had entered safety mode.It was believed that the patient's underlying rhythm was 65 bpm, however this may have changed as the pacing percentage had increased from 57% to 90%.It was noted that the patient was in chronic atrial fibrillation (af), thresholds were 2.8v, and output was 5v.In addition, the lower rate limit was increased from 45 to 65 bpm.This pacemaker remains in service at this time, however technical services (ts) recommended device replacement and return for analysis.No adverse patient effects were reported.

Manufacturer Narrative

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

• Brand Name: ACCOLADE SR
• Type of Device: 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: 16755143
• MDR Text Key: 313489802
• Report Number: 2124215-2023-18054
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559150
• UDI-Public: 00802526559150
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2023

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: 11/18/2017
• Device Model Number: L300
• Device Catalogue Number: L300
• Device Lot Number: 708557
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2023
• Initial Date FDA Received: 04/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2015
• 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: 72 YR
• Patient Sex: Female