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

Model Number L301

Device Problems Pocket Stimulation (1463); Incorrect, Inadequate or Imprecise Result or Readings (1535); Inappropriate or Unexpected Reset (2959)

Patient Problem Device Overstimulation of Tissue (1991)

Event Date 02/16/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient implanted with this pacemaker system presented to the clinic with phrenic nerve/pocket stimulation.Upon device interrogation, it was determined that the pacemaker had entered safety mode.Three power on resets (pors) were detected with the following codes 0x40, 0x0, and 0x0.Subsequently, this pacemaker was explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: ACCOLADE DR
• 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: 18832020
• MDR Text Key: 336849306
• Report Number: 2124215-2024-13117
• 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
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/08/2017
• Device Model Number: L301
• Device Catalogue Number: L301
• Device Lot Number: 704383
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2015
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male