FDA Adverse Event
Injury
Summary report: N
DEEP BRAIN STIMULATION LEAD
MDR report key: 1015581
·
Received March 19, 2008
Report
- Report Number
- 2182207-2008-01368
- Event Type
- Injury
- Date Received
- March 19, 2008
- Report Date
- November 2, 2007
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
JOURNAL REFERENCE: PIBOOLNURAK ET AL. "LEVODOPA RESPONSE IN LONG-TERM BILATERAL SUBTHALAMIC STIMULATION FOR PARKINSON'S DISEASE" MOVEMENT DISORDERS/2007/22/7/990-997. THIS ARTICLE DESCRIBES A LONG-TERM FOLLOW-UP OF 33 PATIENTS WITH DBS THERAPY FOR PARKINSON'S DISEASE. REPORTABLE EVENT: THERE WERE A TOTAL OF 4 ADVERSE EVENT REPORTS OF WORSENING BALANCE DURING THE FOLLOW-UP. NO ADDITIONAL INFORMATION OR OUTCOMES WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEEP BRAIN STIMULATION LEAD | MHY | MEDTRONIC NEUROMODULATION | 3387 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | PROGRAMMER MODEL UNK N=1| EXTENSION MODEL UNK N=2| IMPLANTABLE STIMULATOR MODEL UNK N=1| LEAD MODEL 3387 N=1 |