FDA Adverse Event
Malfunction
Summary report: N
NEUROSTIMULATOR
MDR report key: 3083353
·
Received April 29, 2013
Report
- Report Number
- 3007566237-2013-01470
- Event Type
- Malfunction
- Date Received
- April 29, 2013
- Report Date
- April 10, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PATIENT'S INS FLOATS AROUND TO THE FRONT OF HER BODY. SHE HOPED THE DEVICE WOULD WORK BUT IT DID NOT. EVERY TIME SHE TURNED THE DEVICE ON, SHE WOULD THROW-UP VIOLENTLY. SHE LOST HER INSURANCE SO SHE COULD NOT GO BACK AND HAVE THE DEVICE "FIXED." SHE WEARS EVERYTHING STRETCHY AND DOES NOT LIKE THE DEVICE. SHE WOULD LIKE THE DEVICE REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Description of Event or Problem · 1
ADDITIONAL INFORMATION REPORTED THAT THE PATIENT'S TRIAL SYSTEM WORKED. IT WAS NOTED THAT THE PATIENT HAD GAINED WEIGHT AND HATED HER DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 184863 | NEUROSTIMULATOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |