FDA Adverse Event
Malfunction
Summary report: N
KINETRA
MDR report key: 1890248
·
Received October 22, 2010
Report
- Report Number
- 3004209178-2010-08336
- Event Type
- Malfunction
- Date Received
- October 22, 2010
- Date of Event
- June 1, 2010
- Report Date
- June 28, 2010
- 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
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.
Description of Event or Problem · 1
IT WAS REPORTED THE PT WAS FALLING FREQUENTLY, AND WAS UNSURE IF THE FALLS WERE DUE TO THEIR IMPLANTABLE NEUROSTIMULATOR. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
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 | 49 YR | EXPLANTED:| LEAD: MODEL 3387S, LOT# V291389| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU200594V| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387S, LOT# V291389| IMPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU200593V| PROGRAMMER: MODEL 7436, LOT# NFU020408P| EXPLANTED:| EXPLANTED: |