MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIGILANT EL ICD DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number D233

Device Problem Telemetry Discrepancy (1629)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/29/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that this implantable cardioverter defibrillator (icd) showed difficulties establishing telemetry.The icd was going to be deactivated as the patient was going to hospice.Another device successfully established telemetry with the programmer.Other troubleshooting options were attempted without success.The field representative placed a magnet over the device and toned could be heard.Another programmer or wand was recommended.No adverse patient effects were reported.

• Brand Name: VIGILANT EL ICD DR
• Type of Device: IMPLANTABLE CARDIOVERTER 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: 16767559
• MDR Text Key: 313557303
• Report Number: 2124215-2023-18503
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526587801
• UDI-Public: 00802526587801
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: D233
• Device Catalogue Number: D233
• Device Lot Number: 635110
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2022
• 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: 75 YR
• Patient Sex: Male