FDA Adverse Event
Malfunction
Summary report: N
EXTERNAL NEUROSTIMULATOR
MDR report key: 1823595
·
Received August 27, 2010
Report
- Report Number
- 3007566237-2010-06558
- Event Type
- Malfunction
- Date Received
- August 27, 2010
- Report Date
- August 1, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P970004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
A PATIENT REPORTED NOT FEELING ANY STIMULATION SENSATION IN REGARDS TO THEIR DEVICE. THE PATIENT NOTED THE "DEVICE FELL OUT OF HER BACK". THE ISSUE WAS NOTED AS FOLLOWING AN IMPLANT PROCEDURE, HOWEVER IT IS SUSPECTED THAT THE PATIENT WAS UNDERGOING A TRIAL / TRIAL PERIOD. THE PATIENT'S OUTCOME WAS NOT REPORTED. ADDITIONAL INFORMATION WILL BE REPORTED AS IT BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXTERNAL NEUROSTIMULATOR | LGW | MEDTRONIC NEUROMODULATION | ENS | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN CONVERSION TYPE: MODEL LEADN, LOT# UNK| IMPLANTED:| EXPLANTED: |