FDA Adverse Event
Injury
Summary report: N
DEEP BRAIN STIMULATION LEAD
MDR report key: 1002323
·
Received February 22, 2008
Report
- Report Number
- 2182207-2008-00876
- Event Type
- Injury
- Date Received
- February 22, 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
- DE, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SEE SCANNED PAGES.
Description of Event or Problem · 1
JOURNAL REFERENCE: VOGES, J., R. HIKER, ET AL. (2007). "THIRTY DAYS COMPLICATION RATE FOLLOWING SURGERY PERFORMED FOR DEEP BRAIN STIMULATION." MOVEMENT DISORDERS 22(10): 1486-1489. THE ARTICLE DESCRIBES A RETROSPECTIVE STUDY OF 1,183 PTS TREATED WITH DEEP BRAIN-STIMULATION FOR A NUMBER OF CONDITIONS. DATA WAS COLLECTED FROM FIVE CENTERS. THE GOAL OF THE STUDY WAS TO EVALUATE SERIOUS ADVERSE EVENTS OCCURRING DURING THE FIRST 30 POSTOPERATIVE DAYS. A NUMBER OF PT COMPLICATIONS WERE PRESENTED IN THE ARTICLE. THREE PTS (LEADS N=3) EXPERIENCED FALLS RESULTING IN SCALP INJURY POST DBS SURGERY.
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 YR | Other | BILATERAL SYSTEMS WERE USED IN THE STUDY| UNSPECIFIED |