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

Model Number D233

Device Problems Pacing Problem (1439); Unexpected Therapeutic Results (1631); Under-Sensing (1661)

Patient Problem Syncope/Fainting (4411)

Event Date 05/06/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported, that the patient with this implantable cardioverter defibrillator (icd).Had a syncopal event, prior to a shock delivery.It appears, that there were under sensed beats that caused a delay in the anti-tachycardia pacing delivery.Afterwards a shock was successful for the patient.Different programming options were discussed for this icd that remains in service.No additional 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: 17016269
• MDR Text Key: 316132974
• Report Number: 2124215-2023-26837
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526587801
• UDI-Public: 00802526587801
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960040/S385
• 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: 05/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/27/2023
• Device Model Number: D233
• Device Catalogue Number: D233
• Device Lot Number: 598411
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/08/2023
• Initial Date FDA Received: 05/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2021
• 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 Age: 75 YR
• Patient Sex: Male