FDA Adverse Event
Injury
Summary report: N
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
MDR report key: 3140072
·
Received May 31, 2013
Report
- Report Number
- 3007566237-2013-01805
- Event Type
- Injury
- Date Received
- May 31, 2013
- Report Date
- May 10, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD. PRODUCT TYPE: LEAD. (B)(4).
Additional Manufacturer Narrative · 1
THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. THE THERAPY THE DEVICE WAS USED FOR WAS INTRACTABLE FACIAL PAIN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD AN EVACUATION (PRESUMED TO MEAN EXPLANT) OF THE SUBDURAL LEAD WITH SHORT TERM NEUROLOGICAL DEFICITS. THE DEFICITS RESOLVED AFTER EVACUATION. THERE WERE NO LONG TERM COMPLICATIONS AT 5 YEARS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 241746 | UNKNOWN IMPLANTABLE NEUROSTIMULATOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |