FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEEP BRAIN STIMULATOR
MDR report key: 1329173
·
Received February 25, 2009
Report
- Report Number
- 2182207-2009-01296
- Event Type
- Injury
- Date Received
- February 25, 2009
- Date of Event
- December 31, 2007
- Report Date
- January 14, 2009
- 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
SEE SCANNED PAGES.
Description of Event or Problem · 1
LITERATURE: ZIBETTI M, PESARE M, CINQUEPALMI A, ET AL. ANTIPARKINSONIAN THERAPY MODIFICATIONS IN PD PATIENTS AFTER STN DBS: A RETROSPECTIVE OBSERVATIONAL ANALYSIS. PARKINSONISM RELAT DISORD. 2008; 14(8): 608-612. LITERATURE SUMMARY: DESCRIPTION OF THE MODIFICATIONS OF ALL ANTIPARKINSONIAN TREATMENTS, INCLUDING LEVODOPA, DOPAMINE AGONISTS AND ASSOCIATED ANTIPARKINSONIAN DRUGS SUCH AS COMT AND MAO INHIBITORS, AMANTADINE AND ANTICHOLINERGICS, IN A GROUP OF 67 CONSECUTIVE PD PATIENTS SURGICALLY TREATED BY STN DBS WITH AN ASSESSMENT UP TO 3 YEARS. PATIENT 1 OF 5 HAD DEEP VEIN THROMBOSIS REPORTED TO BE DIRECTLY RELATED TO THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEEP BRAIN STIMULATOR | MHY | MEDTRONIC NEUROMODULATION | IPGNEURO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | EXPLANTED:| IMPLANTED:| EXTENSION: MODEL EXTENSION MVD| EXPLANTED:| LEAD: MODEL LEADMVD |