FDA Adverse Event
Injury
Summary report: N
UNKNOWN NEUROSTIMULATOR
MDR report key: 3317766
·
Received August 29, 2013
Report
- Report Number
- 3007566237-2013-02843
- Event Type
- Injury
- Date Received
- August 29, 2013
- Report Date
- August 1, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT AND HER SYMPTOMS WERE WORSE THAN BEFORE HER REPLACEMENT. THE PATIENT COULDN¿T TALK, COULDN¿T WALK, WAS KNOCKING THINGS OVER, ¿WAS ALL OVER THE PLACE", AND HAD SEIZURE-LIKE MOTIONS. IT WAS STATED THAT THE PATIENT HAD NO CONTROL OF HERSELF. THE CALLER CONTACTED THE HCP WHO TOLD HER IT WAS PROBABLY ANXIETY THAT WAS CAUSING THE SYMPTOMS. IT WAS ALSO REPORTED THAT THE PATIENT PROGRAMMER WAS NOT COMPATIBLE WITH THE PATIENT¿S NEW INS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 426479 | UNKNOWN NEUROSTIMULATOR | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00052 YR | Disability |