FDA Adverse Event
Injury
Summary report: N
RESTORE
MDR report key: 3133604
·
Received May 29, 2013
Report
- Report Number
- 3007566237-2013-01755
- Event Type
- Injury
- Date Received
- May 29, 2013
- Report Date
- May 7, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
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 HAD THEIR IMPLANTABLE NEUROSTIMULATOR (INS) EXPLANTED 2 TO 3 DAYS FOLLOWING IMPLANT (LATE 2012) DUE TO PAIN (¿IT HURT SO BAD HE COULDN'T STAND IT¿). ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 235178 | RESTORE | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |