VIVA¿ QUAD XT CRT-D
Report
- Report Number
- 3004209178-2019-22959
- Event Type
- Injury
- Date Received
- December 3, 2019
- Date of Event
- November 8, 2019
- Report Date
- December 9, 2019
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- NIK
- UDI-DI
- 00643169007222
- PMA / PMN Number
- P010031
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE PATIENT WAS BEING INAPPROPRIATELY SHOCKED BY THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) FOR SINUS TACHYCARDIA. THE DEVICE FEATURE WHICH IS DESIGNED TO WITHHOLD INAPPROPRIATE VENTRICULAR DETECTION BY COMPARING THE PATIENT'S CURRENT QRS WAVEFORM TO A COLLECTED AND STORED TEMPLATE OF THE PATIENT'S QRS WAVEFORM DURING SINUS RHYTHM PERMITTED THERAPY DELIVERY WITH AS LITTLE AS 0% MATCH. COLLECTING A NEW TEMPLATE OF THE PATIENT'S QRS WAVEFORM WAS DISCUSSED. THE CRT-D REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
IT WAS FURTHER REPORTED THAT A NEW TEMPLATE OF THE PATIENT'S QRS WAVEFORM WAS COLLECTED WITH A 90-100% MATCH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1196741 | VIVA¿ QUAD XT CRT-D | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO | NIK | MEDTRONIC PUERTO RICO OPERATIONS CO. | DTBA1QQ | 00643169007222 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Life Threatening| R | 429888 LEAD, 5076-52 LEAD, 6947M62 LEAD |