FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 3051530
·
Received April 10, 2013
Report
- Report Number
- 2649622-2013-04884
- Event Type
- Injury
- Date Received
- April 10, 2013
- Date of Event
- February 18, 2013
- Report Date
- February 18, 2013
- Manufacturer
- MPRI
- Product Code
- NVY
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MY
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US 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 SHORTLY AFTER IMPLANT, THE PATIENT RECEIVED MULTIPLE INAPPROPRIATE SHOCKS DUE TO OVERSENSING, AS WELL AS APPROPRIATE SHOCKS FOR VENTRICULAR TACHYCARDIA (VT). THE PATIENT WAS TREATED WITH MEDICATION, AND 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 |
|---|---|---|---|---|---|---|---|
| 152822 | SPRINT QUATTRO SECURE | DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES | NVY | MPRI | 6947M62 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening | D364VRM IMPLANTABLE DEFIBRILLATOR |