FDA Adverse Event
Malfunction
Summary report: N
IMPLANTABLE NEUROSTIMULATOR
MDR report key: 3327849
·
Received September 5, 2013
Report
- Report Number
- 3007566237-2013-02903
- Event Type
- Malfunction
- Date Received
- September 5, 2013
- Report Date
- August 10, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PATIENT RECEIVED GREAT RELIEF AND THERAPY FROM THE DEVICE BUT THEN IT ¿STOPPED WORKING¿. THE PATIENT HAD THE DEVICE IMPLANTED ABOUT SIX MONTHS TO A YEAR AGO AND IT WORKED FOR A FEW MONTHS. HIS TREMORS WERE GONE AND THEN THE TREMORS CAME BACK A FEW MONTHS AFTER IMPLANT. NO ADDITIONAL FOLLOW UP IS POSSIBLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 440205 | IMPLANTABLE NEUROSTIMULATOR | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |