FDA Adverse Event
Malfunction
Summary report: N
DUAL EXTENSION CARRIER
MDR report key: 1011620
·
Received March 10, 2008
Report
- Report Number
- 2182207-2008-01190
- Event Type
- Malfunction
- Date Received
- March 10, 2008
- Date of Event
- January 30, 2008
- Report Date
- January 30, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THE CARRIER TIP IN THE EXTENSION KIT SNAPPED WHEN IT ENCOUNTERED TOUGH CERVICAL FASCIA. A NEW EXTENSION KIT WAS OPENED AND OPERATED CORRECTLY. THE PT RECOVERED WITHOUT SEQUELA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DUAL EXTENSION CARRIER | MHY | MEDTRONIC NEUROMODULATION | 3655 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | IMPLANTED| EXPLANTED| EXTENSION MODEL 7482A LOT # UNK |