FDA Adverse Event
Summary report: N
DEEP BRAIN STIMULATION DEVICES
MDR report key: 921643
·
Received September 21, 2007
Report
- Report Number
- 2182207-2007-03007
- Date Received
- September 21, 2007
- Report Date
- September 29, 2006
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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: J.D. PUTZKE, ET AL. "BILATERAL THALAMIC DEEP BRAIN STIMULATION: MIDDLE TREMOR CONTROL. JOURNAL OF NEUROLOGY, NEUROSURGERY, AND PSYCHIATRY. 2005; 76 (5): 684-90. THE ARTICLE DESCRIBES A STUDY OF 22 PTS BEING TREATED WITH DBS FOR ESSENTIAL TREMOR. REPORTABLE EVENTS: THE 3387 LEAD (N=7) - OVER THE COURSE OF FOLLOW UP, SEVEN LEADS REQUIRED REPOSITIONING DUE TO THE LOSS OF EFFECT. THE 3387 LEAD (N=2) - TWO PTS HAD LEADS REPLACED DUE TO BREAKAGE. THE 3387 LEAD (N=1), DBS IPG (N=1) ONE PT EXPERIENCED AN INFECTION AFTER 22 MONTHS THAT REQUIRED THE EXPLANT OF THE DBS SYSTEM - LEAD AND IPG (RIGHT SIDE ONLY).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEEP BRAIN STIMULATION DEVICES | MHY | MEDTRONIC NEUROMODULATION | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |