FDA Adverse Event
Summary report: N
DEEP BRAIN STIMULATION DEVICES
MDR report key: 921641
·
Received September 21, 2007
Report
- Report Number
- 2182207-2007-02999
- Date Received
- September 21, 2007
- Report Date
- May 21, 2007
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING FILED UNDER EXEMPTION. SEE SCANNED PAGES.
Description of Event or Problem · 1
JOURNAL REFERENCE: TAVARES, A.L.T., ET AL. "QUANTITATIVE MEASUREMENTS OF ALTERNATING FINGER TAPPING IN PARKINSON'S DISEASE CORRELATE WITH UPDRS MOTOR DISABILITY AND REVEAL THE IMPROVEMENT IN FINE MOTOR CONTROL FROM MEDICATION AND DEEP BRAIN STIMULATION." MOVEMENT DISORDERS. 2004; 20: 1286-1298. THE ARTICLE DESCRIBES A STUDY INVOLVING 33 PTS BEING TREATED WITH B-STN DBS FOR PARKINSONS DISEASE. THE STUDY INVESTIGATED THE DIFFERENT ASPECTS OF MOTOR CONTROL. REPORTABLE EVENTS: IPG (N=2), TWO PTS HAD ONE SIDE OF THEIR BILATERAL SYSTEMS REPLACED DUE TO INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEEP BRAIN STIMULATION DEVICES | MHY | MEDTRONIC NEUROMODULATION | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |