FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
MDR report key: 3111072
·
Received May 14, 2013
Report
- Report Number
- 3007566237-2013-01606
- Event Type
- Malfunction
- Date Received
- May 14, 2013
- Report Date
- April 24, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT LOST WEIGHT AND KEPT FLIPPING THEIR IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT EVERYTHING WAS "KINKED TOGETHER" AND IT WAS A "BIG SHORTED MESS." IT WAS ADDED THE PATIENT HAD TWIDDLER'S SYNDROME. A SUPPLEMENTAL REPORT WILL BE SENT IF ANY ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN MANUFACTURING REPORT #3004209178-2010-02459.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 213374 | UNKNOWN IMPLANTABLE NEUROSTIMULATOR | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |