FDA Adverse Event
Malfunction
Summary report: N
KINETRA
MDR report key: 2673491
·
Received July 30, 2012
Report
- Report Number
- 3004209178-2012-06194
- Event Type
- Malfunction
- Date Received
- July 30, 2012
- Report Date
- June 29, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 7436, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3387-40, LOT# V002359, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 3387-40, LOT# V002332, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THREE YEARS AGO THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) BECAME "STUCK OFF" FOR THREE DAYS. THERE WAS NO REPORTED PATIENT INJURY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KINETRA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MDT PUERTO RICO OPERATIONS CO | 7428 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |