FDA Adverse Event
Injury
Summary report: N
UNKNOWN SPINAL CORD STIMULATOR
MDR report key: 2093936
·
Received May 16, 2011
Report
- Report Number
- 3007566237-2011-03558
- Event Type
- Injury
- Date Received
- May 16, 2011
- Date of Event
- April 19, 2011
- Report Date
- April 19, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PT DID NOT FEEL STIMULATION IN THE TARGET AREA. THE LEAD WAS REPLACED DUE TO HIGH IMPEDANCE ABOUT ONE YEAR AFTER THE INITIAL IMPLANT. INTRAOPERATIVE MEASUREMENTS WERE GREATER THAN 10,000 OHMS. NO FURTHER PT COMPLICATION WAS REPORTED.
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 | 43 YR | Required Intervention | IMPLANTED:| EXPLANTED:| LEAD: MODEL 39565, LOT# UNK |