FDA Adverse Event
Injury
Summary report: N
DEEP BRAIN STIMULATION LEAD
MDR report key: 1014499
·
Received March 17, 2008
Report
- Report Number
- 2182207-2008-01318
- Event Type
- Injury
- Date Received
- March 17, 2008
- Report Date
- February 26, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
.
Description of Event or Problem · 1
JOURNAL REFERENCE: EGIDI ET AL. A SURVEY OF ITALIAN CASES OF DYSTONIA TREATED BY DEEP BRAIN STIMULATION. J OF NEUROLOGICAL SCIENCES 2007: 51(4): 153-8. THE ARTICLE DESCRIBES A RETROSPECTIVE SURVEY WITH THE AIM OF PRESENTING THE COMPLETE SERIES OF DYSTONIC PATIENTS TREATED WITH BILATERAL DBS IN ORDER TO DESCRIBE LOCAL CURRENT PRACTICES. A TOTAL OF 7 CENTERS PARTICIPATED IN THE SURVEY AND OPERATED ON 69 PATIENTS. SURGICAL COMPLICATIONS OCCURRED IN 13 OF THE 69 PATIENTS (19%). ONE PATIENT EXPERIENCED SYMPTOMATIC HEMORRHAGE. TREATMENT AND OUTCOME INFORMATION 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 | Other | IPG UNK (N=1 OR 2)| LEAD UNK (N=1)| LEAD EXTENSION UNK (N=2) |