FDA Adverse Event
Injury
Summary report: N
NEU_INS_STIMULATOR
MDR report key: 3200721
·
Received July 1, 2013
Report
- Report Number
- 3007566237-2013-02169
- Event Type
- Injury
- Date Received
- July 1, 2013
- Date of Event
- May 29, 2013
- Report Date
- June 6, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD. (B)(4). ANALYSIS OF THE LEAD FOUND REPORTED SETSCREW MARKS WERE OBSERVED ON THE 8-15 LEG OF THE LEAD AND NO SETSCREW MARKS WERE OBSERVED ON THE 0-7 LEG OF THE LEAD.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A MALFUNCTIONING LEAD. IT WAS NOTED THERE WAS NO STIMULATION ON ONE SIDE. THE LEAD WAS EXPLANTED. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 299283 | NEU_INS_STIMULATOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |