FDA Adverse Event
Injury
Summary report: N
KINETRA
MDR report key: 1053630
·
Received May 23, 2008
Report
- Report Number
- 3004209178-2008-02779
- Event Type
- Injury
- Date Received
- May 23, 2008
- Date of Event
- March 1, 2008
- Report Date
- April 23, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PT NEVER HAD THERAPEUTIC EFFECT. HE WAS "SHAKING LIKE A WILD MAN" AND HAVING PROBLEMS BREATHING. THE SYMPTOMS CLEARED WHEN THE STIMULATOR WAS TURNED OFF; HE ONLY HAD A LITTLE TREMOR. THE PT WAS AT HOME AND HIS STATUS WAS "FAIR". ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KINETRA | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | 7428 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention | EXPLANTED:| EXPLANTED:| LEAD: MODEL 3389S, LOT,# V080811, IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482, LOT # NHU170002V IMPLANTED:| EXTENSION: MODEL 7482, LOT # NHU169997V IMPLANTED:| PROGRAMMER: MODEL 7436, LOT # NFU018567P| EXPLANTED:| LEAD: MODEL 3389S, LOT # V080811, IMPLANTED: |