FDA Adverse Event
Malfunction
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 6924077
·
Received October 6, 2017
Report
- Report Number
- 2649622-2017-11755
- Event Type
- Malfunction
- Date Received
- October 6, 2017
- Date of Event
- March 23, 2017
- Report Date
- July 19, 2017
- Manufacturer
- MPRI
- Product Code
- NVY
- UDI-DI
- 00643169082267
- PMA / PMN Number
- P920015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD A FEW NON-SUSTAINED VENTRICULAR TACHYCARDIA (VT) EPISODES DUE TO T-WAVE OVERSENSING (TWOS) POST VENTRICULAR SENSE. FOLLOW UP WITH THE PHYSICIAN'S OFFICE INDICATED THAT NO REPROGRAMMING WAS DONE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 701803 | SPRINT QUATTRO SECURE | DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES | NVY | MPRI | 6947M62 | 00643169082267 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR |