FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 2864963
·
Received December 10, 2012
Report
- Report Number
- 2649622-2012-17564
- Event Type
- Injury
- Date Received
- December 10, 2012
- Date of Event
- September 28, 2012
- Report Date
- October 18, 2012
- Manufacturer
- MPRI
- Product Code
- NVY
- PMA / PMN Number
- P920015/S055
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A ROUTINE X-RAY POST PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD WAS FOUND TO BE DISLODGED. THE PATIENT WAS RETURNED TO THE LAB FOR A LEAD RE-POSITIONING. THE LEAD REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE SYSTEMS LONGEVITY CLINICAL STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPRINT QUATTRO SECURE | DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES | NVY | MPRI | 6947M |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |