DEEP BRAIN STIMULATION LEAD
Report
- Report Number
- 2182207-2007-04246
- Event Type
- Injury
- Date Received
- December 5, 2007
- Report Date
- October 17, 2007
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
JOURNAL REFERENCE: NOVAK, ET AL. "TWO CASES OF ISCHEMIA ASSOCIATED WITH SUBTHALAMIC NUCLEUS STIMULATOR IMPLANTATION FOR ADVANCED PARKINSON'S DISEASE". MOVEMENT DISORDERS, 2006, 21:1477-1483. DUE TO THE LIMITATIONS OF THE DATA, THE REPORTABLE EVENTS ARE BEING SUBMITTED BY COMPLICATION TYPE. THE EXACT RELATIONSHIP BETWEEN EACH PATIENT, THE DEVICES USED AND THE COMPLICATIONS EXPERIENCED WAS NOT PROVIDED. IT IS POSSIBLE THAT EACH PATIENT MAY HAVE EXPERIENCED MORE THAN ONE COMPLICATION.
JOURNAL REFERENCE: NOVAK, ET AL. "TWO CASES OF ISCHEMIA ASSOCIATED WITH SUBTHALAMIC NUCLEUS STIMULATOR IMPLANTATION FOR ADVANCED PARKINSON'S DISEASE". MOVEMENT DISORDERS, 2006, 21:1477-1483. THE ARTICLE DESCRIBES TWO CASE STUDIES THAT INVOLVE ISCHEMIA ASSOCIATED WITH THE IMPLANT OF SUBTHALAMIC NUCLEUS STIMULATORS IN ADDITION, OTHER COMPLICATIONS FROM A SERIES OF 41 PATIENTS TREATED WITH DBS FOR SYMPTOMS RELATED TO ADVANCED STAGE PD OVER THE LAST 5.5 YEARS ARE ALSO PRESENTED. REPORTABLE EVENT: TWO PATIENTS (MODEL 3389 LEAD N=2) EXPERIENCED SUBDURAL HEMATOMAS. NO SYMPTOM, TREATMENT OR OUTCOME INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEEP BRAIN STIMULATION LEAD | MHY | MEDTRONIC NEUROMODULATION | 3389 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK YR | Other | DBS LEAD MODEL 3389 (N=1)| IPG SOLETRA 7426 (N=2)| LEAD EXTENSIONS (N=2)| MICROELECTRODE-RECORDING (MFG FHC) |