FDA Adverse Event
Malfunction
Summary report: N
EXTERNAL NEUROSTIMULATOR
MDR report key: 1915529
·
Received November 5, 2010
Report
- Report Number
- 3007566237-2010-08962
- Event Type
- Malfunction
- Date Received
- November 5, 2010
- Date of Event
- October 1, 2010
- Report Date
- October 15, 2010
- 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
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PT WAS HAVING PROBLEMS WITH THEIR DEVICE DURING A TRIAL. IT WAS STATED THE PT'S DEVICE WOULD "RAMP UP" WHEN SHE CHANGED POSTURES, AND ALSO AT TIMES WHEN THE PT WAS NOT MOVING OR USING THE PT PROGRAMMER. THE PT WAS ALSO HAVING PROBLEMS WITH THE PT PROGRAMMER, AND WAS UNABLE TO ADJUST HER STIMULATION. PT INFO WAS NOT REPORTED. ADD'L INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADD'L INFO 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 | IMPLANTED:| UNK CONVERSION TYPE: MODEL LEADN, LOT# UNK| EXPLANTED: |