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

Model Number L311

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Under-Sensing (1661); Low impedance (2285)

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

Event Date 01/01/2021

Event Type  malfunction  

Event Description

It was reported that this pacemaker exhibited oversensing of fine noisy signals in atrial tachy response (atr) episodes on the right atrial (ra) lead channel.The noisy artifact is a known issue.Additionally, there was intermittent undersensing on the ra channel.The pacemaker also exhibited out of range pacing impedance alerts for several years and had varying impedances from low out of range to within range with an approximately 700-ohm difference.Technical services (ts) suggested reprogramming.Ts noted that the patient presented to the emergency room (er) for syncope, however, they do not believe it is related to the atr episodes as the atrs were not new.The patient is ventricular pace dependent, but there were no signs of oversensing on the ventricular episodes and right ventricular (rv) lead measurements remained within range.The device remains in use.No adverse patient effects were reported.

• Brand Name: ACCOLADE MRI DR
• Type of Device: IMPLANTABLE 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: 19173468
• MDR Text Key: 341420248
• Report Number: 2124215-2024-24844
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559228
• UDI-Public: 00802526559228
• 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: Other
• Type of Report: Initial
• Report Date: 04/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/22/2023
• Device Model Number: L311
• Device Catalogue Number: L311
• Device Lot Number: 541357
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2021
• 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: 96 YR
• Patient Sex: Male