UNKNOWN EXTERNAL NEUROSTIMULATOR
Report
- Report Number
- 3007566237-2012-02714
- Event Type
- Injury
- Date Received
- November 15, 2012
- Report Date
- October 16, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
(B)(4).
(B)(4).
FURTHER REVIEW INDICATED THAT THE EVENT OCCURRED DURING THE USE OF AN EXTERNAL NEUROSTIMULATOR (ENS), NOT AFTER THE IMPLANTATION OF AN IMPLANTABLE NEUROSTIMULATOR (INS). ADDITIONAL INFORMATION RECEIVED REPORTED THAT PATIENT WAS CALM DURING STITCH REMOVAL. SEVEN WEEKS LATER, IT WAS REPORTED THAT THE SEIZURES WERE NOT DEVICE RELATED. THE REPORTER STATED THAT THE EVENT HAPPENED DUE TO ANXIETY WHILE THE STITCHES FROM THE LEAD INSERTION SITE WERE BEING REMOVED. IT WAS REPORTED THAT THE PATIENT HADN'T EXPERIENCED ANY ADDITIONAL SEIZURE EPISODES, AS FAR AS THE REPORTER KNEW.
IT WAS REPORTED THAT WHEN THE PATIENT WAS AT AN APPOINTMENT TO HAVE THEIR STITCHES REMOVED AFTER IMPLANTATION OF THE IMPLANTABLE NEUROSTIMULATOR (INS), THEY LOST CONSCIOUS AND SUFFERED A SEIZURE. IT WAS NOTED THAT THE PATIENT HAD NO PRIOR HISTORY OF EPILEPSY AND IT WAS BELIEVED TO BE AN ISOLATED INCIDENT (NO FURTHER EPISODES REPORTED) MOST LIKELY DUE TO VAGAL NERVE REACTION FROM THE SUTURE REMOVAL PROCEDURE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN EXTERNAL NEUROSTIMULATOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC NEUROMODULATION | NEU_ENS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R |