FDA Adverse Event
Malfunction
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 3152856
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-05710
- Event Type
- Malfunction
- Date Received
- June 8, 2013
- Date of Event
- January 29, 2013
- Report Date
- March 14, 2013
- Manufacturer
- MPRI
- Product Code
- NVY
- PMA / PMN Number
- P920015
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WV, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: 5076 IMPLANTABLE PACING LEAD - 2005 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE SHORTLY AFTER IMPLANT. THE LEAD WILL CONTINUE TO BE MONITORED, AND 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 |
|---|---|---|---|---|---|---|---|
| 257840 | SPRINT QUATTRO SECURE | DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES | NVY | MPRI | 6947M55 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00050 YR | (B)(4) IMPLANTABLE DEFIBRILLATOR |