FDA Adverse Event
Injury
Summary report: N
DEEP BRAIN STIMULATION LEAD
MDR report key: 1019053
·
Received March 24, 2008
Report
- Report Number
- 2182207-2008-01530
- Event Type
- Injury
- Date Received
- March 24, 2008
- Report Date
- November 27, 2007
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.
Description of Event or Problem · 1
JOURNAL REFERENCE: TIR ET AL. "EXHAUSTIVE, ONE-YR F/U OF SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION IN A LARGE, SINGLE-CENTER COHORT OF PARKINSONIAN PTS." 2007/61/2/297-304. THIS ARTICLE DESCRIBES A STUDY THAT ENROLLED 103 CONSECUTIVE PTS WITH PARKINSON'S DISEASE WHO WERE TREATED WITH BILATERAL STN-DBS. THE PTS WERE FOLLOWED FOR A PERIOD OF 12 MOS. REPORTABLE EVENT: NINE PTS EXPERIENCED HYPOPHONIA POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEEP BRAIN STIMULATION LEAD | MHY | MEDTRONIC NEUROMODULATION | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | PROGRAMMER MODEL UNK N=1| LEAD MODEL UNK N=1| IMPLANTABLE PULSE GENRATOR MODEL UNK N=1| EXTENSION MODEL UNK N=2 |