FDA Adverse Event
Injury
Summary report: N
DEEP BRAIN STIMULATION LEAD
MDR report key: 949302
·
Received November 15, 2007
Report
- Report Number
- 2182207-2007-03815
- Event Type
- Injury
- Date Received
- November 15, 2007
- Report Date
- October 14, 2007
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
JOURNAL REFERENCE: CHUNG, ET AL. "BILATERAL EFFECTS OF UNILATERAL SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION IN ADVANCED PARKINSON'S DISEASE." EUR NEUROL 2006; 56: 127-132. THE ARTICLE DESCRIBES THE RESULTS OF A PROSPECTIVE STUDY OF CONSECUTIVE PATIENTS BEING TREATED WITH UNILATERAL DEEP BRAIN STIMULATION FOR PARKINSONS DISEASE SYMPTOMS. PATIENTS WERE EVALUATED AT 3 AND 6 MONTHS. A NUMBER OF PATIENT COMPLICATIONS WERE REPORTED. REPORTABLE EVENT(S): A PATIENT EXPERIENCED A TRANSIENT MEMORY IMPAIRMENT POST DBS IMPLANT OF THE LEFT STN. NO INFORMATION ON TREATMENT 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 | YR | Other | IMPLANTABLE NEUROSTIMULATOR| LEAD EXTENSION |