FDA Adverse Event
Injury
Summary report: N
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
MDR report key: 3202589
·
Received July 2, 2013
Report
- Report Number
- 3007566237-2013-02187
- Event Type
- Injury
- Date Received
- July 2, 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 Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT¿S STIMULATOR DID NOT ¿EVEN LAST 6 MONTHS.¿ THE PATIENT WAS TOLD THAT THE STIMULATOR WOULD LAST 5 YEARS. IN ADDITION, THE ¿LEADERS¿ (PRESUMED TO BE LEAD WIRES) HAD TO BE CHANGED 4 TIMES IN THE PAST 2 YEARS. THE PATIENT HAD ¿GOTTEN SO BAD HE CAN¿T EVEN WALK.¿ THE PATIENT WAS ATTEMPTING TO FIND A PHYSICIAN TO REMOVE THE STIMULATOR. CONTACT INFORMATION WAS REFUSED AND ADDITIONAL FOLLOW UP COULD NOT BE DONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 302531 | 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 |