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

Model Number L311

Device Problem Pacing Problem (1439)

Patient Problems Arrhythmia (1721); Fall (1848)

Event Date 08/20/2022

Event Type  Injury  

Event Description

It was reported that this patient with this pacemaker had presented to the emergency department after several falls.Technical services (ts) was consulted and noted several pacemaker mediated tachycardia (pmt) that were terminated by the device.In one of the episode, patient rhythm appear to have accelerated after the pmt event.This pacemaker remains in service.No adverse patient effects were reported.

Event Description

It was reported that this patient with this pacemaker had presented to the emergency department after several falls.Technical services (ts) was consulted and noted several pacemaker mediated tachycardia (pmt) that were terminated by the device.In one of the episode, patient rhythm appear to have accelerated after the pmt event.This pacemaker remains in service.No 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: 15820970
• MDR Text Key: 303895853
• Report Number: 2124215-2022-47800
• Device Sequence Number: 1
• Product Code: LWP
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 12/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/02/2019
• Device Model Number: L311
• Device Catalogue Number: L311
• Device Lot Number: 308867
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Sex: Male