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

Model Number L331

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); Failure to Read Input Signal (1581); Under-Sensing (1661); High Capture Threshold (3266)

Patient Problems Chest Pain (1776); Pleural Effusion (2010)

Event Date 10/19/2023

Event Type  Injury  

Event Description

It was reported that this implantable pacemaker exhibited high pacing thresholds, low amplitude, noise, undersensing and loss of capture on the right ventricular channel.Additionally, the patient has been experiencing pleural effusion and chest pain.The patient was hospitalized.At this time, no changes have been performed.This device remains in service.No further adverse patient effects were reported.

Manufacturer Narrative

Amendment: additional information was received detailing that the root cause of the issues was due to the right ventricular lead experiencing perforation.It was determined that there were no issues with this device.This record no longer meets reportable criteria.

Event Description

It was reported that this implantable pacemaker exhibited high pacing thresholds, low amplitude, noise, undersensing and loss of capture on the right ventricular channel.Additionally, the patient has been experiencing pleural effusion and chest pain.The patient was hospitalized.At this time, no changes have been performed.This device remains in service.No further adverse patient effects were reported.Additional information was received detailing that the root cause of the previously mentioned issues was a perforation from the right ventricular lead.It was determined that there were no issues with the device and a lead replacement procedure was performed.This device remains in service.No further adverse patient effects were reported.

• Brand Name: ACCOLADE MRI EL 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: 18449980
• MDR Text Key: 332169189
• Report Number: 2124215-2024-00352
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/28/2023
• Device Model Number: L331
• Device Catalogue Number: L331
• Device Lot Number: 967672
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/04/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2021
• 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 Outcome(s): Hospitalization
• Patient Age: 75 YR