FDA Adverse Event
Injury
Summary report: N
NEUROSTIMULATOR
MDR report key: 3240798
·
Received July 22, 2013
Report
- Report Number
- 3007566237-2013-02423
- Event Type
- Injury
- Date Received
- July 22, 2013
- Report Date
- July 1, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID NEU_UNKNOWN_PROG, SERIAL# UNKNOWN, IMPLANTED: 2006-(B)(6), PRODUCT TYPE PROGRAMMER, PHYSICIAN PRODUCT ID NEU_UNKNOWN_EXT, (B)(4).
Description of Event or Problem · 1
THE SKIN BEHIND THE EAR OF THE EXTENSION WIRE WAS WORN. IT WAS POSSIBLE TO SEE THE WIRE WITH INFECTION. THE PATIENT WENT TO THE HOSPITAL. ADDITIONAL INFORMATION RECEIVED INDICATED THE INFECTION COULD NOT BE CONFIRMED DUE TO THE PATIENT NOT STAYING IN THE HOSPITAL. THE PATIENT WAS GOING TO GO TO THE HOSPITAL FOR FURTHER TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 340610 | NEUROSTIMULATOR | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00061 YR | Required Intervention |