FDA Adverse Event
Injury
Summary report: N
EXTERNAL NEUROSTIMULATOR
MDR report key: 1970149
·
Received January 14, 2011
Report
- Report Number
- 3007566237-2011-00402
- Event Type
- Injury
- Date Received
- January 14, 2011
- Date of Event
- December 16, 2010
- Report Date
- December 29, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- 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 TWO DAYS FOLLOWING THE INITIATION OF THE STIMULATION TRIAL THAT BEGAN ON (B)() 2010, THE PT EXPERIENCED INCREASED PAIN TO HER LEG. THE PT WENT TO THE HOSPITAL ON (B)(6) 2010. THE LEADS WERE REMOVED AND THE PT WAS TOLD SHE HAD AN INFECTION. THE PT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2010. ADD'L INFO HAS BEEN REQUESTED; A F/U REPORT WILL BE SUBMITTED 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 | Required Intervention | IMPLANTED:| IMPLANTED:| LEAD: MODEL 3874, LOT# V568162| LEAD: MODEL 3874, LOT# V568162| EXPLANTED:| EXPLANTED: |