FDA Adverse Event
Malfunction
Summary report: N
UNK
MDR report key: 1080256
·
Received July 22, 2008
Report
- Report Number
- 2182207-2008-04251
- Event Type
- Malfunction
- Date Received
- July 22, 2008
- Date of Event
- June 1, 2008
- Report Date
- June 24, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
RESULTS: EXTENSION PASSER. SEE SCANNED PAGE.
Description of Event or Problem · 1
IT WAS REPORTED THE PASSER IN THE EXTENSION KIT BROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK | MHY | MEDTRONIC NEUROMODULATION | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | EXTENSION MODEL 7482A LOT#UNK| EXPLANTED| IMPLANTED |