FDA Adverse Event
Injury
Summary report: N
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
MDR report key: 2902374
·
Received January 8, 2013
Report
- Report Number
- 3007566237-2013-00072
- Event Type
- Injury
- Date Received
- January 8, 2013
- Report Date
- December 14, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE LEAD PRODUCT ID 3387, PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A LEAD WAS PLACED IN THE LEFT SUBTHALAMIC NUCLEUS (STN) ON (B)(6) 2012. THE REPORTER INDICATED THAT THE NEUROSURGEON WAS "NOT HAPPY" WITH ITS PLACEMENT AND REVISED IT A WEEK LATER DURING PLACEMENT OF THE RIGHT STN LEAD. IT WAS NOTED THAT THE PROCEDURE WAS VERY SUCCESSFUL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 9716 | UNKNOWN IMPLANTABLE NEUROSTIMULATOR | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |