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

Model Number L311

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); Low impedance (2285)

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

Event Date 02/16/2024

Event Type  malfunction  

Event Description

It was reported that the patient with this pacemaker device exhibited noisy signals and loss of capture (loc) on the right ventricular (rv) channel.The rv impedances went half from what the measurements were during implant.This device currently remains in service.No adverse patient effects were reported.

Manufacturer Narrative

This report contains correction in entire section e initial reporter and section g2 report source.

Event Description

It was reported that the patient with this pacemaker device exhibited noisy signals and loss of capture (loc) on the right ventricular (rv) channel.The rv impedances went half from what the measurements were during implant.This device currently remains in service.No adverse patient effects were reported.

• 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: 18991663
• MDR Text Key: 338901419
• Report Number: 2124215-2024-18849
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526559228
• UDI-Public: 00802526559228
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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: 764661
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2024
• 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: 84 YR
• Patient Sex: Female