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

Model Number D232

Device Problem Defibrillation/Stimulation Problem (1573)

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

Event Date 03/28/2023

Event Type  Injury  

Event Description

It was reported that the patient with this implantable cardioverter defibrillator (icd) experienced a ventricular tachycardia (vt) episode.The device inhibited therapy for 7 minutes and eventually delivered anti-tachycardia pacing (atp) and electric shocks which successfully converted the episode.No adverse patient effects were reported.At this time, this device remains in service.

• Brand Name: VIGILANT EL ICD VR
• 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: 16773493
• MDR Text Key: 313629611
• Report Number: 2124215-2023-18767
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526587788
• UDI-Public: 00802526587788
• 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: Other,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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/10/2021
• Device Model Number: D232
• Device Catalogue Number: D232
• Device Lot Number: 259816
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2019
• 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; Life Threatening
• Patient Age: 56 YR
• Patient Sex: Male