FDA Adverse Event
Malfunction
Summary report: N
PRIMEADVANCED
MDR report key: 3233499
·
Received July 18, 2013
Report
- Report Number
- 3007566237-2013-02399
- Event Type
- Malfunction
- Date Received
- July 18, 2013
- Report Date
- June 25, 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: 3877-45, PRODUCT TYPE: LEAD. PRODUCT ID: 37081, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3550-29, PRODUCT TYPE: ACCESSORY. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT SOMETIME IN (B)(6) 2013 THE PATIENT WAS AT NIGHT SCHOOL NEAR "(B)(6)" AND FELT A SENSATION THAT THE PATIENT DESCRIBED AS "SPARKLERS GOING OFF IN HIS ENTIRE TRUNK AREA." IT WAS NOTED THAT THE PATIENT WALKED AWAY FROM THE MACHINERY, LEFT CLASS AND FELT FINE ABOUT 20 MINUTES LATER. IT WAS NOTED THAT THE PATIENT THOUGHT STIMULATION WAS TURNED OFF AT THE TIME THAT THIS OCCURRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 336285 | PRIMEADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC NEUROMODULATION | 37702 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |