MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION; IMPLANTABLE DEFIBRILLATOR

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 12/26/2023

Event Type  malfunction  

Event Description

It was reported that this tachy device delivered inappropriately one shock.Reprograming of the device was discussed.This device remains in service.No further adverse patient effects were reported.

Event Description

It was reported that this tachy device delivered inappropriately one shock.Reprograming of the device was discussed.This device remains in service.No further adverse patient effects were reported.

Manufacturer Narrative

Added additional product information details.

• Type of Device: IMPLANTABLE DEFIBRILLATOR
• 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: 18513556
• MDR Text Key: 332869284
• Report Number: 2124215-2024-01796
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/05/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2020
• 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 Age: 71 YR
• Patient Sex: Male