FDA Adverse Event
Malfunction
Summary report: N
VIGILANT EL ICD VR
MDR report key: 12054721
·
Received June 23, 2021
Report
- Report Number
- 2124215-2021-13286
- Event Type
- Malfunction
- Date Received
- June 23, 2021
- Date of Event
- April 18, 2021
- Report Date
- June 23, 2021
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWS
- UDI-DI
- 00802526587788
- PMA / PMN Number
- P960040/S385
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECEIVED INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) AND SHOCKS DUE TO POSSIBLE ATRIAL FIBRILLATION (AF) WITH RAPID VENTRICULAR RESPONSE (RVR).TECHNICAL SERVICES (TS) DISCUSSED MEDICATION WITH CLINICIAN, AND RECOMMENDED ELECTRO PHYSIOLOGIST (EP) CONSULT FOR NEXT STEPS. THIS PRODUCT REMAINS IN-SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LOCAL AREA FIELD REPRESENTATIVE WAS CONTACTED FOR ADDITIONAL INFORMATION, HOWEVER AT THIS TIME NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 948050 | VIGILANT EL ICD VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | LWS | BOSTON SCIENTIFIC CORPORATION | D232 | 267217 | 00802526587788 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR |