FDA Adverse Event
Injury
Summary report: N
DEEP BRAIN STIMULATION LEAD
MDR report key: 963713
·
Received December 12, 2007
Report
- Report Number
- 2182207-2007-04352
- Event Type
- Injury
- Date Received
- December 12, 2007
- Report Date
- October 17, 2007
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
JOURNAL REFERENCE: ZHANG, ET AL. "DEEP BRAIN STIMULATION IN THE TREATMENT OF SECONDARY DYSTONIA." CHINESE MEDICAL JOURNAL, 2006; 119(24):2069-2074.
Description of Event or Problem · 1
JOURNAL REFERENCE: ZHANG, ET. AL. "DEEP BRAIN STIMULATION IN THE TREATMENT OF SECONDARY DYSTONIA." CHINESE MEDICAL JOURNAL. 2006; 119(24): 2069-2074. THE ARTICLE DESCRIBES THE RESULTS FROM A STUDY THAT INVOLVED A SERIES OF 9 PATIENTS TREATED WITH UNILATERAL AND BILATERAL DEEP DRAIN STIMULATION (DBS) FOR MANAGEMENT OF SYMPTOMS RELATED TO SECONDARY DYSTONIA. A NUMBER OF COMPLICATIONS WERE DESCRIBED. REPORTABLE EVENT: A MALE PATIENT EXPERIENCED LETHARGY POST DBS THERAPY INITIATION. THE SYMPTOM WAS ALLEVIATED AFTER REPROGRAMMING THE STIMULATING PARAMETERS.
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 | 24 YR | Required Intervention | LEAD MODEL 3389 (N=1)| KINETRA MODEL 7428| LEAD EXTENSIONS (N=2) |