FDA Adverse Event
Injury
Summary report: N
VIGILANT EL ICD DR
MDR report key: 20301989
·
Received September 25, 2024
Report
- Report Number
- 2124215-2024-60051
- Event Type
- Injury
- Date Received
- September 25, 2024
- Date of Event
- August 29, 2024
- Report Date
- September 25, 2024
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWS
- UDI-DI
- 00802526587801
- PMA / PMN Number
- P960040/S385
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE PACING THAT RESULTED IN AN ARRYTHMIA. TECHNICAL SERVICES (TS) REVIEWED THE DEVICE DATA AND DETERMINED THAT THE ARRYTHMIA WAS TRIGGERED DUE TO FUNCTIONAL UNDERSENSING OF A PREMATURE VENTRICULAR CONTRACTION (PVC). THE PVC FELL INTO BLANKING AND WHEN THE ATRIOVENTRICULAR CYCLE TIMER EXPIRED, A PACE WAS DELIVERED ON THE RIGHT VENTRICULAR (RV) CHANNEL THAT INDUCED THE ARRYTHMIA. THE ARRHYTHMIA WAS SUCCESSFULLY DETECTED BY THE DEVICE AND DELIVERED A SHOCK. TS PROVIDED REPROGRAMMING CONSIDERATIONS FOR POTENTIAL FUTURE PVC'S EPISODES. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS ICD REMAINS IN SERVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2234396 | VIGILANT EL ICD DR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) | LWS | BOSTON SCIENTIFIC CORPORATION | D233 | 589814 | 00802526587801 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Male | Required Intervention| H |