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

Model Number L301

Device Problem Off-Label Use (1494)

Patient Problem Atrial Fibrillation (1729)

Event Date 05/24/2022

Event Type  malfunction  

Event Description

It was reported that this pacemaker is not approved for magnetic resonance imaging (mri).The local area representative noted they have performed mris.Which led to the patient experiencing atrial fibrillation with a rapid ventricular response.At this time, this pacemaker remains in service.

• Brand Name: ACCOLADE DR
• Type of Device: PACEMAKER
• 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: 14682718
• MDR Text Key: 293937180
• Report Number: 2124215-2022-21130
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/18/2017
• Device Model Number: L301
• Device Catalogue Number: L301
• Device Lot Number: 718967
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2015
• 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: 92 YR
• Patient Sex: Female