FDA Adverse Event
Malfunction
Summary report: N
KAPPA
MDR report key: 3152829
·
Received June 8, 2013
Report
- Report Number
- 3004209178-2013-08842
- Event Type
- Malfunction
- Date Received
- June 8, 2013
- Report Date
- March 4, 2013
- Manufacturer
- MEDTRONIC
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
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 2001 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS NO TELEMETRY OR A MAGNET RESPONSE FROM THE DEVICE. THE DEVICE BATTERY IS DEPLETED. THE PATIENT IS INTUBATED SECONDARY TO VENTRICULAR FIBRILLATION. THE DEVICE IS STILL 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 |
|---|---|---|---|---|---|---|---|
| 257648 | KAPPA | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC | KDR701 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00058 YR | 5076 IMPLANTABLE PACING LEAD |