FDA Adverse Event
Injury
Summary report: N
DEEP BRAIN STIMULATION LEAD
MDR report key: 1002324
·
Received February 22, 2008
Report
- Report Number
- 2182207-2008-00878
- 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
.
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 PATIENTS 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. TWO PTS EXPERIENCED SEIZURES (ONE EACH) POST DBS SURGERY. BOTH PTS HAD CARDIOVASCULAR RISK FACTORS. TREATMENT AND OUTCOME INFO WAS NOT PROVIDED.
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 | UNSPECIFIED| BILATERAL SYSTEMS WERE USED IN THE STUDY |