MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIGILANT X4 CRT-D; IMPLANTABLE DEVICE

Model Number G247

Device Problems Pacing Problem (1439); Failure to Read Input Signal (1581); Unexpected Therapeutic Results (1631); Under-Sensing (1661)

Patient Problems Cardiac Arrest (1762); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/30/2022

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) undersensed the patients ventricular fibrillation (vf) which led to delay in therapy.Upon further review, it was noted there was some inappropriate ventricular pacing being delivered during the ventricular fibrillation (vf) episode.Additionally, the vf was quite fine.Currently, the patient is hospitalized on extracorporeal membrane oxygenation (ecmo).At this time, the device remains in service.

Manufacturer Narrative

Correction to b2, and h6 fields (patient code and impact code).

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) undersensed the patients ventricular fibrillation (vf) which led to delay in therapy.Upon further review, it was noted there was some inappropriate ventricular pacing being delivered during the ventricular fibrillation (vf) episode.Additionally, the vf was quite fine.Currently, the patient is hospitalized on extracorporeal membrane oxygenation (ecmo).At this time, the device remains in service.

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) undersensed the patients ventricular fibrillation (vf) which led to delay in therapy.Upon further review, it was noted there was some inappropriate ventricular pacing being delivered during the ventricular fibrillation (vf) episode.Additionally, the vf was quite fine.Currently, the patient is hospitalized on extracorporeal membrane oxygenation (ecmo).At this time, the device remains in service.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Dimensional analysis of the header was completed.Each port measured as expected.The device was then exposed to simulated heart load conditions, and the defibrillation, pacing, and sensing functions were tested.Impedance testing was completed, and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.Correction to b2, and h6 fields (patient code and impact code).

• Brand Name: VIGILANT X4 CRT-D
• Type of Device: IMPLANTABLE DEVICE
• 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: 15164618
• MDR Text Key: 297242719
• Report Number: 2124215-2022-29070
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/16/2022

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: 06/28/2021
• Device Model Number: G247
• Device Catalogue Number: G247
• Device Lot Number: 219294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2022
• Initial Date FDA Received: 08/04/2022
• Supplement Dates Manufacturer Received: 09/15/2022; 11/07/2022
• Supplement Dates FDA Received: 09/26/2022; 11/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2019
• 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): Hospitalization; Other; Life Threatening
• Patient Age: 47 YR
• Patient Sex: Male