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

Model Number L311

Device Problems Premature Discharge of Battery (1057); Failure to Capture (1081); Pacing Problem (1439); Battery Problem (2885); Interrogation Problem (4017)

Patient Problems Bradycardia (1751); Dizziness (2194)

Event Date 02/26/2024

Event Type  Injury  

Event Description

It was reported that the patient with this pacemaker was evaluated in clinic for a routine follow up with the physician.At the moment of the evaluation, the patient stated feeling dizzy.An electrocardiogram was performed, and it was noted a heart rate of 29 beats per minute (bpm) and no signs of pacing.The device was not able to be interrogated.A magnet was applied, and no response was observed.A device changeout procedure was performed due to premature battery depletion and it was explanted and replaced.It was noted the battery of this device depleted at less than 4 years after it was implanted.No additional adverse patient effects were reported.It is expected to receive this device for analysis.

• 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: 18917065
• MDR Text Key: 337816362
• Report Number: 2124215-2024-15942
• 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: Physician
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/20/2022
• Device Model Number: L311
• Device Catalogue Number: L311
• Device Lot Number: 518515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2020
• 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): Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Female