FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN SPINAL CORD STIMULATOR
MDR report key: 2030451
·
Received March 9, 2011
Report
- Report Number
- 3007566237-2011-01784
- Event Type
- Malfunction
- Date Received
- March 9, 2011
- Date of Event
- January 1, 2010
- Report Date
- February 23, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
RECEIVED INFO, THE PT WAS UNABLE TO GET HER DEVICE TO WORK AFTER REPLACEMENT DUE TO LEAD ISSUES, AND THAT SHE NO LONGER NEEDS THE DEVICE. PT STATES, HER CURRENT NEUROLOGIST SAID, SHE WAS MISDIAGNOSED AND NEVER NEEDED TO HAVE AN IMPLANT. HER NEUROLOGIST OPERATED ON HER AND CAN CURE HER OF PAIN ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN SPINAL CORD STIMULATOR | LGW | MEDTRONIC NEUROMODULATION | IPGNEURO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | IMPLANTED:| EXPLANTED:| UNK CONVERSION TYPE: MODEL LEADN, LOT #UNK |