FDA Adverse Event
Injury
Summary report: N
DEEP BRAIN STIMULATION
MDR report key: 1021105
·
Received March 27, 2008
Report
- Report Number
- 2182207-2008-01601
- 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
THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.
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. TWO PTS WITH BILATERAL DBS FOR DYSTONIA HAD ONLY MILD DIFFICULTIES WITH SWALLOWING. NONE OF THESE CHANGES WERE SIGNIFICANT ENOUGH TO IMPACT DAILY LIFE OR WORK ABILITY.
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 | IMPLANTABLE PULSE GENERATOR MODEL IPGNEURO LOT#UNK| IMPLANTED| EXPLANTED| IMPLANTED| EXTENSION MODEL EXTENSION LOT#UNK| LEAD MODEL 3387 LOT #UNK| IMPLANTED| IMPLANTED| PROGRAMMER MODEL PROGRAMMER LOT#UNK| IMPLANTED| EXPLANTED| EXPLANTED| EXTENSION MODEL EXTENSION LOT#UNK| EXPLANTED| EXPLANTED |