MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIGILANT X4 CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR

Model Number G247

Device Problems Premature Discharge of Battery (1057); Incorrect, Inadequate or Imprecise Result or Readings (1535); Interrogation Problem (4017)

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

Event Date 05/03/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) triggered a fault code 1007 related to charge time exceeded.The battery was at end-of-life state and was recommended to be explanted.The crt-d was no longer able to be monitored due to limited battery capacity.The crt-d has been explanted at this time and has been returned for analysis.No additional adverse patient effects were reported.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) triggered a fault code 1007 related to charge time exceeded.The battery was at end-of-life state and was recommended to be explanted.The crt-d was no longer able to be monitored due to limited battery capacity.The crt-d has been explanted at this time and has been returned for analysis.No additional adverse patient effects were reported.

Manufacturer Narrative

A thorough evaluation of the device was performed upon receipt at our post market quality assurance laboratory.Visual inspection of the device noted no anomalies.Review of device memory indicated that a charge timeout alert (> 45 seconds) had been recorded.The device case was opened, and visual inspection noted that one of the two high voltage (hv) capacitors was slightly swollen.The hv capacitor was analyzed, and it was concluded that the hv capacitor experienced internal arcing caused by a low resistance pathway between anode and cathode plates within the capacitor.This capacitor issue impacted the ability of the device to provide shock therapy because the hv capacitors could not be fully charged, but brady pacing, telemetry, and other device functionality remained available.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VIGILANT X4 CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY 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: 17017820
• MDR Text Key: 316091739
• Report Number: 2124215-2023-27077
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589287
• UDI-Public: 00802526589287
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/15/2021
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 214102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2023
• Initial Date FDA Received: 05/30/2023
• Supplement Dates Manufacturer Received: 11/09/2023
• Supplement Dates FDA Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2019
• 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): Required Intervention; Hospitalization
• Patient Age: 85 YR
• Patient Sex: Female