FDA Adverse Event
Malfunction
Summary report: N
EXTERNAL NEUROSTIMULATOR
MDR report key: 2182324
·
Received July 11, 2011
Report
- Report Number
- 3007566237-2011-05291
- Event Type
- Malfunction
- Date Received
- July 11, 2011
- Date of Event
- June 16, 2011
- Report Date
- June 16, 2011
- 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
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT EXPERIENCED A SHOCKING SENSATION WHEN SHE SAT DOWN OR COUGHED. SHE WAS FEELING STIMULATION FROM HER SYSTEM. THE PT WAS UNDERGOING A NEUROSTIMULATION TRIAL. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP 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 |