FDA Adverse Event
Malfunction
Summary report: N
ENRHYTHM
MDR report key: 3071711
·
Received April 22, 2013
Report
- Report Number
- 3004209178-2013-06693
- Event Type
- Malfunction
- Date Received
- April 22, 2013
- Report Date
- February 26, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, 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 PRODUCT: 5092 IMPLANTABLE PACING LEAD (B)(6) 2006. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE HAD HAD A POWER ON RESET (POR), DATE UNKNOWN. NO REPROGRAMMING HAD BEEN DONE. THE DEVICE HAS SINCE BEEN EXPLANTED AND REPLACED FOR END OF LIFE (EOL). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 172134 | ENRHYTHM | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | P1501DR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00082 YR | ZYPJUSBV COMPETITOR IMPLANTABLE PACING LEAD |