FDA Adverse Event
Malfunction
Summary report: N
DEEP BRAIN STIMULATION LEAD
MDR report key: 1053253
·
Received May 28, 2008
Report
- Report Number
- 6000153-2008-02859
- Event Type
- Malfunction
- Date Received
- May 28, 2008
- Date of Event
- February 1, 2008
- Report Date
- April 29, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT IMPEDANCES WERE GREATER THAN 4000 OHMS ON ALL OR SOME OF THE BIPOLAR PAIRS. THE SYSTEM ALWAYS HAD HIGH IMPEDANCES. THE PATIENT'S THERAPY HAD NOT CHANGED. PER THE HCP, NO ACTION NEEDED TO BE TAKEN AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. PLEASE REFERENCE MFG. REPORT #6000153200802860.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEEP BRAIN STIMULATION LEAD | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3387 | V085139 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | IMPLANTABLE NEURO STIMULATOR MODEL 7428| IMPLANTED:| EXPLANTED:| EXPLANTED:| LOT# NFD108116H| EXPLANTED:| EXTENSION MODEL 7482 LOT# NHY169368V| EXPLANTED:| EXTENSION MODEL 7482 LOT# NHY169367V| IMPLANTED:| IMPLANTED:| LEAD MODEL# 3387S-40| IMPLANTED:| PROGRAMMER MODEL 7436 LOT# NFY018434P |