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

Model Number L331

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/23/2020

Event Type  malfunction  

Manufacturer Narrative

This device has been returned for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that this pacemaker was interrogated prior to implant and was found to be operating in safety mode.The device was not implanted and was returned for analysis.There was no patient involvement.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, the clinically observed error message was confirmed.It was confirmed that the device underwent a reset due to a temporary, intermittent loss of battery power which resulted in the observed error message.Following the reset, the device reverted to a safety mode.The exact root cause of the loss of battery power could not be determined as the device operated normally throughout laboratory testing.This device has been returned for analysis.This report will be updated upon completion of analysis.

Event Description

It was reported that this pacemaker was interrogated prior to implant and was found to be operating in safety mode.The device was not implanted and was returned for analysis.There was no patient involvement.

• Brand Name: ACCOLADE MRI EL 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: 11212576
• MDR Text Key: 228169951
• Report Number: 2124215-2021-01233
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559266
• UDI-Public: 00802526559266
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150012/S000
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2022
• Device Model Number: L331
• Device Catalogue Number: L331
• Device Lot Number: 899886
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1