KINETRA
Report
- Report Number
- 3004209178-2014-12571
- Event Type
- Malfunction
- Date Received
- July 7, 2014
- Report Date
- June 16, 2014
- 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
- MI, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT PRODUCTS: PRODUCT ID 3389S-40, LOT # V126057, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT # V091844, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 7482A95, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A95, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 7436 , SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT.
CONCOMITANT PRODUCTS: PRODUCT ID 3389S-40, LOT# V126057, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT# V091844, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 7482A95, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A95, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 7436, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4)
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR HEALTHCARE PROFESSIONAL OR MANUFACTURING REPRESENTATIVE. THE PATIENT HAD HAD AN APPOINTMENT ON (B)(6) 2014 AND HAD ONE SCHEDULED FOR (B)(6) 2015. IT WAS NOTED THAT THE PATIENT WAS FUNCTIONING QUITE WELL WITH THEIR NEUROSTIMULATOR BUT HAD VIOLENT TREMORS IN ALL FOUR EXTREMITIES WHEN THE SYSTEM IS OFF. THE PATIENT¿S TREMORS HAD BEEN LESS SEVERE IN 2010 WHEN THE SYSTEM WAS INADVERTENTLY TURNED OFF IN THE AIRPORT SO THEY WERE ABLE TO TALK THE PARAMEDICS THROUGH SYSTEM RE-START.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY BUT WAS WORKING WITH THEIR MANUFACTURING REPRESENTATIVE OR HEALTHCARE PROFESSIONAL. THERE WAS AN APPOINTMENT ON (B)(6). THE PATIENT WAS WORKING WITH THEIR DOCTOR BUT THERE WAS NO SOLUTION IN SIGHT. THE PATIENT HAD HAD DEEP BRAIN STIMULATOR SURGERY IN 2008 AND SINCE TREMORS HAD DEGENERATED TO AN UNCONTROLLABLE DEGREE IN ALL 4 LIMBS WITH THE NEUROSTIMULATOR SYSTEM SHUT OFF. THE EVENT HAD OCCURRED ONCE IN THE AIRPORT DUE TO A STRAY SIGNAL AND PATIENT WAS ABLE TO RE-START THERE WITH THE HELP OF PARAMEDICS. ADDITIONAL REVIEW OF THE EVENT INDICATED THAT  WAS REPORTED THAT THE DEVICE WAS TURNED OFF AND THE PATIENT WAS UNABLE TO TURN THE IMPLANTABLE NEUROSTIMULATOR (INS) BACK ON DUE TO TREMORS. THERAPY DID WORK WHEN IT WAS TURNED ON.WAS NOT APPLICABLE TO THE REPORTED EVENT AND IS BEING CAPTURED IN A SEPARATE EVENT.
IT WAS REPORTED THAT THE DEVICE WAS TURNED OFF AND THE PATIENT WAS UNABLE TO TURN THE IMPLANTABLE NEUROSTIMULATOR (INS) BACK ON DUE TO TREMORS. THERAPY DID WORK WHEN IT WAS TURNED ON. 4 YEARS PRIOR TO THE DATE OF THIS REPORT THE PATIENT¿S INS THERAPY TURNED OFF IN THE AIRPORT. TREMORS WERE NOT AS BAD AT THAT TIME AND HE WAS ABLE TO TURN THE INS BACK ON. THE PATIENT HAD BEEN SURROUNDED BY PARAMEDICS AND CHANGED THE PATIENT PROGRAMMER BATTERIES AND TURNED THERAPY ON. IT WAS NOTED THAT THE PATIENT LIVED IN FEAR EVERY DAY THAT THE INS WOULD TURN OFF AND HE WOULD NOT BE ABLE TO TURN IT BACK ON. ADDITIONAL INFORMATION WAS REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 393457 | KINETRA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 7428 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00065 YR |