FDA Adverse Event
Malfunction
Summary report: N
KINETRA
MDR report key: 1111637
·
Received August 13, 2008
Report
- Report Number
- 3004209178-2008-04911
- Event Type
- Malfunction
- Date Received
- August 13, 2008
- Date of Event
- June 1, 2008
- Report Date
- July 16, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
FOR STIMULATION CHANGES WITH PALPATION.
Description of Event or Problem · 1
THE PATIENT FELL ON HIS ARM AND SIDE EXPERIENCED A LOSS OF THERAPEUTIC EFFICACY WHICH IS UNRELATED STIMULATION THERAPY. MOVEMENT AND PALPATION PRODUCED STIMULATION CHANGES. THE PT'S SYMPTOMS WERE LOCATED AT THE LEAD EXTENSION CONNECTION LOCATION. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED 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 | Required Intervention | IMPLANTED| EXTENSION MODEL 7482| EXPLANTED| EXPLANTED| PROGRAMMER MODEL 7436| IMPLANTED| LEAD MODEL 3387 |