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

Model Number L311

Device Problem Under-Sensing (1661)

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

Event Date 03/08/2024

Event Type  malfunction  

Event Description

It was reported that the patient with this pacemaker device exhibited undersensing.Upon review, there were irregular amplitude, however the rhythm was consistent with the ventricular fibrillation (vf).The rhythm was undersensed at times so the ventricular pacing was delivered.At the end of the event, the vf persisted, and no other ventricular events were recorded after that.The presenting electrogram (egm) showed no deflection which indicated capture.The health care professional (hcp) called the patient, but no response received.This device remains in service.No adverse patient effects were reported.

Manufacturer Narrative

Correction to b5 describe event or problem.Added additional details.

Event Description

It was reported that the patient with this pacemaker device exhibited undersensing.Upon review, there were irregular amplitude, however the rhythm was consistent with the ventricular fibrillation (vf).The rhythm was undersensed at times so the ventricular pacing was delivered.At the end of the event, the vf persisted, and no other ventricular events were recorded after that.The presenting electrogram (egm) showed no deflection which indicated capture.The health care professional (hcp) called the patient, but no response received.This device remains in service.No adverse patient effects were reported.This supplemental report is being filed as the undersensing allegation appears to be due to programmed sensitivity, and to clarify the pacemaker would not treat ventricular fibrillation (vf).This device operated as expected.

• Brand Name: ACCOLADE MRI DR
• Type of Device: PACEMAKERS
• 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: 18989800
• MDR Text Key: 338742507
• Report Number: 2124215-2024-18619
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/04/2020
• Device Model Number: L311
• Device Catalogue Number: L311
• Device Lot Number: 358983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2018
• 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: 69 YR
• Patient Sex: Male