FDA Adverse Event
Malfunction
Summary report: N
SPINAL CORD STIMULATOR
MDR report key: 1232532
·
Received November 13, 2008
Report
- Report Number
- 2182207-2008-07455
- Event Type
- Malfunction
- Date Received
- November 13, 2008
- Date of Event
- October 12, 2008
- Report Date
- November 12, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE PATIENT INCREASED STIMULATION SHE HAD INCREASED HEADACHES. IT FELT LIKE THE 'LEADS WERE SWOLLEN' TO THE PATIENT. THERE WAS NO KNOWN INCIDENT OR ACCIDENT RELATED TO THE COMPLAINT. THE SYMPTOMS BEGAN 4 DAYS PRIOR TO THE REPORT DATE. THE DEVICE SYSTEM WAS EXPLANTED (DATE UNK). ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPINAL CORD STIMULATOR | LGW | MEDTRONIC NEUROMODULATION | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | IMPLANTED:| EXPLANTED:| LEAD: MODEL UNK |