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

Model Number L331

Device Problem Pacing Problem (1439)

Patient Problems Fall (1848); Head Injury (1879); Syncope/Fainting (4411)

Event Date 09/29/2022

Event Type  Injury  

Event Description

It was reported that this pacemaker recorded episodes of pacemaker mediated tachycardia (pmt).The caller mentioned that the patient experienced an unwitnessed fall resulting in a small head wound.The timing appears to be similar and there is reasonable evidence suggesting that the patient experienced a syncopal episode related to the pmt episode.Lead measurements were within normal range.The system remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this pacemaker recorded episodes of pacemaker mediated tachycardia (pmt).The caller mentioned that the patient experienced an unwitnessed fall resulting in a small head wound.The timing appears to be similar and there is reasonable evidence suggesting that the patient experienced a syncopal episode related to the pmt episode.Lead measurements were within normal range.The system remains in service.No additional 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: 15637415
• MDR Text Key: 302055675
• Report Number: 2124215-2022-42536
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/16/2023
• Device Model Number: L331
• Device Catalogue Number: L331
• Device Lot Number: 954914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2021
• 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): Other
• Patient Age: 92 YR
• Patient Sex: Female