KINETRA
Report
- Report Number
- 3004209178-2013-01146
- Event Type
- Malfunction
- Date Received
- January 30, 2013
- Report Date
- January 14, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 7436, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3389S-40, LOT # V063959, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT # V050963, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. (B)(4).
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF STIMULATION UPON WALKING THROUGH AN AIRPORT SECURITY DEVICE. THE PATIENT STATED THAT SHE "THINKS IT TURNED OFF" AFTER PASSING THROUGH THE GATES WITH IT TURNED ON, AFTER WHICH IT "JUST DIDN'T SEEM RIGHT." IT WAS ALSO REPORTED THAT THE PATIENT WAS "MISSING THE STIMULATION" DURING HER PREVIOUS APPOINTMENTS WITH HER HEALTH CARE PROVIDER (HCP). THE PATIENT REPORTED THAT THE VOLTAGE MEASUREMENT OF HER IMPLANT "HASN'T CHANGED" AND THAT IT IS NOT "TIME TO REPLACE THE INTERNAL BATTERY YET." THE PATIENT ALSO REPORTED THAT HER "VOLTAGE IS LOW." THE PATIENT WAS SCHEDULED TO SEE HER HCP THE DAY FOLLOWING THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 41313 | KINETRA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 7428 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |