FDA Adverse Event
Malfunction
Summary report: N
KINETRA
MDR report key: 1994345
·
Received January 14, 2011
Report
- Report Number
- 3004209178-2011-00400
- Event Type
- Malfunction
- Date Received
- January 14, 2011
- Report Date
- January 5, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PATIENT'S DEVICE WAS ACCIDENTALLY TURNED OFF FOR SEVERAL DAYS AFTER A MAGNET WAS PLACED OVER IT. WHEN THE DEVICE WAS TURNED BACK AFTER BEING RESET, HE RECEIVED TREMENDOUS RESULTS (WAS ABLE TO STAND UP AND WALK AROUND), BETTER THAN HE HAD BEEN IN SOME TIME. WITHIN A FEW DAYS, HE WAS BACK TO BASELINE EFFECTIVENESS. HE HAS HAD VERY GOOD RESULTS FROM HIS THERAPY AND WAS HAPPY WITH THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KINETRA | MHY | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 7428 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | EXPLANTED:| EXPLANTED:| LEAD: MODEL 3389, LOT# J0333665V| EXTENSION: MODEL 7482, LOT# NHU062820V| EXPLANTED:| LEAD: MODEL 3389S-40, LOT# V009814| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU134437V |