FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN DEEP BRAIN STIMULATOR
MDR report key: 2100663
·
Received May 12, 2011
Report
- Report Number
- 3007566237-2011-03450
- Event Type
- Malfunction
- Date Received
- May 12, 2011
- Date of Event
- April 1, 2009
- Report Date
- July 8, 2009
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
RECEIVED INFORMATION FROM THE PHYSICIAN REPORTING HIGH IMPEDANCE ISSUES WHEN USING THE MICROELECTRODE RECORDING WITH STIMPILOT. NO FURTHER INFORMATION WAS PROVIDED.
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 |