FDA Adverse Event
Injury
Summary report: N
SPRINT QUATTRO SECURE
MDR report key: 2953504
·
Received February 9, 2013
Report
- Report Number
- 2649622-2013-01134
- Event Type
- Injury
- Date Received
- February 9, 2013
- Date of Event
- October 31, 2012
- Report Date
- November 1, 2012
- Manufacturer
- MPRI
- Product Code
- NVY
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, 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. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO T-WAVE OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 56640 | SPRINT QUATTRO SECURE | DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES | NVY | MPRI | 6947M62 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00061 YR | Life Threatening | (B)(4) IMPLANTABLE CARDIAC DEFIBRILLATOR |