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

Model Number L311

Device Problem Failure to Capture (1081)

Patient Problem Pain (1994)

Event Date 08/28/2022

Event Type  Injury  

Event Description

It was reported that the patient with this pacemaker was admitted to the hospital and exhibited pain.Loss of capture was noted and the pacemaker was reprogrammed to different outputs, after which staff informed the patient that therapy had been turned off, and the pain continues.This pacemaker remains implanted.No additional adverse patient effects were reported.

Event Description

It was reported that the patient with this pacemaker was admitted to the hospital and exhibited pain.Loss of capture was noted and the pacemaker was reprogrammed to different outputs, after which staff informed the patient that therapy had been turned off, and the pain continues.This pacemaker remains implanted.No additional adverse patient effects were reported.Additional information was received and the patient has been put in palliative care.No additional adverse patient effects were reported.

• Brand Name: ACCOLADE MRI DR
• Type of Device: 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: 15391260
• MDR Text Key: 299567629
• Report Number: 2124215-2022-35122
• 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: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: L311
• Device Catalogue Number: L311
• Device Lot Number: 635023
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 90 YR
• Patient Sex: Female