FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEEP BRAIN STIMULATOR
MDR report key: 2160651
·
Received July 7, 2011
Report
- Report Number
- 3007566237-2011-05159
- Event Type
- Injury
- Date Received
- July 7, 2011
- Report Date
- June 13, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT VISITED THE PHYSICIAN DUE TO THE RETURN OF SYMPTOMS. THE PT WAS REPROGRAMMED AND AN X-RAY WAS PERFORMED. THERE WAS "SOME BREAKAGE" FOUND AT THE PROXIMAL END OF THE LEAD. AN EXPLANT AND REPLACEMENT OF THE LEAD WAS PERFORMED DURING THE WEEK OF (B)(6) 2011. THE PT, THEN, RECEIVED "PROPER" THERAPY. THERE WAS NO INJURY TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEEP BRAIN STIMULATOR | MHY | MEDTRONIC NEUROMODULATION | UNKNOWN | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention | LEAD: MODEL 3389, LOT# UNK| IMPLANTED:| EXPLANTED: |