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

Model Number L311

Device Problems Failure to Capture (1081); Under-Sensing (1661); High Capture Threshold (3266)

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

Event Date 01/18/2023

Event Type  malfunction  

Event Description

It was reported that the right atrial (ra) channel on the pacemaker had loss of capture and high capture thresholds initially post implant.The device was reprogrammed.It was noted that the ra channel was getting better thresholds.No new transmissions have been received since the event.More than a year later, there was loss of capture (loc) and undersensing on the atrial channel.Technical services (ts) reviewed the reports and noted that the atrial tachycardia was sensed, but the sinus p-wave was undersensed.It was noted that the atrial pace seemed to be capturing.Ts suggested reprogramming and performing a chest x-ray as the undersensing and capture occurs intermittently.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 55112-5798 ; 6515826168
• MDR Report Key: 18970401
• MDR Text Key: 338506797
• Report Number: 2124215-2024-17876
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: L311
• Device Catalogue Number: L311
• Device Lot Number: 674968
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2022
• 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: 73 YR
• Patient Sex: Female