FDA Adverse Event
Malfunction
Summary report: N
KINETRA
MDR report key: 2211121
·
Received August 8, 2011
Report
- Report Number
- 3004209178-2011-06151
- Event Type
- Malfunction
- Date Received
- August 8, 2011
- Date of Event
- April 1, 2011
- Report Date
- August 29, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT SUFFERED A FALL ON HIS FOREHEAD IN APRIL AND AFTERWARDS HAD LEG CRAMPS AND DIFFICULTY TALKING AND WALKING. 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 |
|---|---|---|---|---|---|---|---|
| 1 | KINETRA | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 7428 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Male | EXPLANTED| EXPLANTED | EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU164166V| EXTENSION: MODEL 7482A51, LOT# NHU164167V| IMPLANTED| IMPLANTED| IMPLANTED| IMPLANTED | LEAD: MODEL 3389S-40, LOT# V038036| LEAD: MODEL 3389S-40, LOT# V063950| IMPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU164167V| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3389S-40, LOT# V063950| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3389S-40, LOT# V038036| EXPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU164166V| IMPLANTED: |