FDA Adverse Event
Malfunction
Summary report: N
DEEP BRAIN STIMULATION LEAD
MDR report key: 2081413
·
Received April 22, 2011
Report
- Report Number
- 6000153-2011-03002
- Event Type
- Malfunction
- Date Received
- April 22, 2011
- Date of Event
- April 22, 2010
- Report Date
- December 1, 2010
- Manufacturer
- MPROC, VILLALBA
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE PHYSICIAN NOTICED THERE WAS A "DEVIATION" BETWEEN ELECTRODES #0 AND #1. THE LEAD WAS NOT IMPLANTED AND A NEW LEAD WAS THEN USED WITHOUT FURTHER INCIDENT. THERE WERE NO PATIENT INJURIES REPORTED. SEE ALSO MANUFACTURER REPORT #6000153-2011-03003.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEEP BRAIN STIMULATION LEAD | MHY | MPROC, VILLALBA | 3387 | V441615 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR |