FDA Adverse Event
Injury
Summary report: N
DEEP BRAIN STIMULATION
MDR report key: 1021111
·
Received March 27, 2008
Report
- Report Number
- 2182207-2008-01599
- Event Type
- Injury
- Date Received
- March 27, 2008
- Report Date
- December 3, 2007
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
KISS ZH, DOIG-BEYAERT K, ELIASZIW M, TSUI J, HAFFENDEN A, SUCHOWERSKY O. THE CANADIAN MULTICENTRE STUDY OF DEEP BRAIN STIMULATION FOR CERVICAL DYSTONIA. BRAIN. 2007; 130(PT 11): 2879-2886. THIS ARTICLE DESCRIBES A STUDY INVOLVING BILATERAL GPI DEEP BRAIN STIMULATION IN 10 PTS WITH SEVERE, CHRONIC, MEDICATION-RESISTANT CERVICAL DYSTONIA. ONE PT WITH BILATERAL DBS FOR DYSTONIA HAD TRANSIENT FACIAL WEAKNESS IMMEDIATELY POST-OPERATIVELY THAT RESOLVED BEFORE THE 3-MONTH VISIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEEP BRAIN STIMULATION | MHY | MEDTRONIC NEUROMODULATION | 3387 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED| IMPLANTED| EXTENSION MODEL EXTENSION LOT #UNK| EXPLANTED| IMPLANTED| IMPLANTED| EXPLANTED| IMPLANTABLE PULSE GENERATOR MODEL IPGNEURO LOT#UNK| IMPLANTED| LEAD MODEL 3387 LOT #UNK| PROGRAMMER MODEL PROGRAMMER LOT#UNK| EXPLANTED| IMPLANTED| EXPLANTED| EXTENSION MODEL EXTENSION LOT#UNK |