FDA Adverse Event
Injury
Summary report: N
UNKNOWN NEUROSTIMULATOR
MDR report key: 2990555
·
Received March 5, 2013
Report
- Report Number
- 3007566237-2013-00685
- Event Type
- Injury
- Date Received
- March 5, 2013
- Report Date
- February 18, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD. PRODUCT TYPE: LEAD. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD A FRAYED LEAD THAT WAS REPAIRED ON (B)(6) 2009. IT WAS REPORTED THAT EVERYTHING WAS FINE AFTER THE LEAD WAS FIXED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 94238 | UNKNOWN NEUROSTIMULATOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00037 YR | Required Intervention |