FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN NEUROSTIMULATOR
MDR report key: 3922841
·
Received July 9, 2014
Report
- Report Number
- 3007566237-2014-01900
- Event Type
- Malfunction
- Date Received
- July 9, 2014
- Report Date
- June 16, 2014
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, PRODUCT TYPE EXTENSION. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED ON (B)(6) 2014 THAT THE REPORTER WANTED TO KNOW IF THERE WAS A WAY TO TEST JUST THE EXTENSION FOR A SHORT. THE REPORTER WAS MADE AWARE OF THE SITUATION ¿LAST WEEK.¿ FOUR DAYS LATER IT WAS REPORTED THAT THERE WAS AN IMPEDANCE EXPLORATION CASE DONE ON (B)(6) 2014. THE PATIENT HAD ¿HIGHS AND LOWS.¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 400007 | UNKNOWN NEUROSTIMULATOR | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |