FDA Adverse Event
Injury
Summary report: N
KINETRA
MDR report key: 3961629
·
Received July 28, 2014
Report
- Report Number
- 3004209178-2014-13600
- Event Type
- Injury
- Date Received
- July 28, 2014
- Report Date
- July 7, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS INITIALLY REPORTED IN (B)(6) 2013 THAT ON APPROXIMATELY (B)(6) 2013, THE PATIENT LOST THEIR APPETITE AND HAD MOVEMENT INCONVENIENCE. THE PATIENTS FAMILY WANTED THE PATIENT TO BE REPROGRAMMED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS REPLACED WITH A NEW DEVICE ON (B)(6) 2014.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 439366 | KINETRA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 7428 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00076 YR | Required Intervention |