FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEEP BRAIN STIMULATOR
MDR report key: 1658298
·
Received April 12, 2010
Report
- Report Number
- 3007566237-2010-02942
- Event Type
- Injury
- Date Received
- April 12, 2010
- Date of Event
- March 12, 2010
- Report Date
- March 12, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B) (4).
Description of Event or Problem · 1
LITERATURE: FERRAYE MU, DEBU B, FRAIX V, ET AL. EFFECTS OF PEDUNCULOPONTINE NUCLEUS AREA STIMULATION ON GAIT DISORDERS IN PARKINSON'S DISEASE. BRAIN. JAN;133(PT 1):205-214. SUMMARY: THE STUDY LOOKED AT THE EFFECTS OF STIMULATING THE PEDUNCULOPONTINE NUCLEUS (PPN) AREA IN SIX PTS WITH SEVERE FREEZING OF GAIT DUE TO PARKINSON'S DISEASE (PD). THE PTS HAD BEEN UNRESPONSIVE TO LEVODOPA AND SUBTHALAMIC NUCLEUS (STN) STIMULATION. EVENT: ONE PT EXPERIENCED GLOBAL WORSENING OF THEIR PARKINSONISM (FREEZING) WITH PPN STIMULATION. SEE LITERATURE ARTICLE WITH MFR REPORT #3007566237-2010-02940.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEEP BRAIN STIMULATOR | MHY | MEDTRONIC NEUROMODULATION | IPG | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Other | LEAD: MODEL 3389, LOT# UNK| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3389, LOT# UNK| EXPLANTED:| IMPLANTED: |