FDA Adverse Event
Injury
Summary report: N
DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES
MDR report key: 2964692
·
Received February 15, 2013
Report
- Report Number
- 2649622-2013-01902
- Event Type
- Injury
- Date Received
- February 15, 2013
- Date of Event
- December 4, 2012
- Report Date
- December 4, 2012
- Manufacturer
- MPRI
- Product Code
- NVY
- PMA / PMN Number
- P920015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, 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).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO FULLY EXTEND THE HELIX AFTER APPROXIMATELY TWENTY TURNS. ADDITIONALLY, THERE WAS APPROXIMATELY 1 TO 2 MILLIMETERS OF SPACE STILL SHOWING. IT WAS ALSO REPORTED THAT THERE WERE SMALL R-WAVES. REPROGRAMMING WAS COMPLETED TO ADJUST THE SENSING AND THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 66522 | DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES | NVY | MPRI | 6947M62 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00077 YR | Hospitalization| R | (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |