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

Model Number G224

Device Problems Premature Discharge of Battery (1057); Battery Problem (2885)

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

Event Date 01/10/2024

Event Type  malfunction  

Manufacturer Narrative

At this time, no further information is available.Should relevant additional information become available this report will be updated.

Event Description

It was reported that the battery of this implantable cardiac resynchronization therapy defibrillator (crt-d) device was suspected to be depleting prematurely.The remaining estimated longevity decreased from 11 years to 5 years between follow ups.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.This device remains in service.No adverse patient effects were reported.

Manufacturer Narrative

At this time, no further information is available.Should relevant additional information become available this report will be updated.

Event Description

It was reported that the battery of this implantable device was suspected to be depleting prematurely.The estimated longevity decreased not as expected, from eleven to five and a half years, within an unspecified time period.A request was made to have data from this device analyzed.Data analysis confirmed the battery appeared to be depleting more quickly than expected.Device replacement was recommended.The battery status was being constantly reassessed and new replacement windows were being provided.This device was replaced and is expected to be returned for analysis.The estimated longevity at the time of the replacement procedure was one year left.No additional adverse patient effects were reported.

• Brand Name: VIGILANT 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: 18533875
• MDR Text Key: 333107374
• Report Number: 2124215-2024-02424
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/05/2023
• Device Model Number: G224
• Device Catalogue Number: G224
• Device Lot Number: 505421
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2021
• 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 Outcome(s): Required Intervention; Hospitalization
• Patient Age: 73 YR