FDA Adverse Event
Injury
Summary report: N
UNKNOWN NEUROSTIMULATOR
MDR report key: 3200408
·
Received July 1, 2013
Report
- Report Number
- 3007566237-2013-02171
- Event Type
- Injury
- Date Received
- July 1, 2013
- Date of Event
- March 25, 2013
- Report Date
- June 7, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 3487A, SERIAL# UNKNOWN, IMPLANTED: 2004-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED LEAD MIGRATION, LEADING TO A LOSS OF STIMULATION, A LOSS OF THERAPEUTIC EFFECT, AND STIMULATION IN THE WRONG LOCATION. THE PATIENT EXPERIENCED PAIN AND LESS THAN 50% THERAPY RELIEF. IT WAS REPORTED THAT THE PATIENT REQUIRED HOSPITALIZATION, SURGICAL INTERVENTION, AND REPROGRAMMING. FOLLOWING THE INTERVENTION EFFECTIVE THERAPY WITH GOOD RESULTS FOR THE PATIENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 298760 | UNKNOWN NEUROSTIMULATOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00045 YR | Hospitalization| R |