BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 2822465 · Received November 7, 2012

    Report

    Report Number
    3004209178-2012-09991
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Report Date
    October 8, 2012
    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
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID 7436, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE STIMULATION WAS TURNED ON, THE PATIENT FELT A "TINGLY FEELING" ON THE RIGHT SIDE OF HIS BODY AND HIS EYES, WHICH INITIALLY STARTED THREE MONTHS AGO. IT OCCURRED ONCE AT THAT TIME AND THEN DID NOT OCCUR AGAIN UNTIL (B)(6) AND (B)(6). DUE TO THE SHAKING AND TINGLING ON THE RIGHT SIDE OF THE BODY, THE PATIENT SHUT STIMULATION OFF. HE HAD NOT HAD ANY REOCCURRENCES SINCE STIMULATION WAS SHUT OFF AND THERE HAD BEEN NO FALLS OR TRAUMA. THE PATIENT WAS AT THE CLINIC AND WHEN THE HCP (HEALTH CARE PROFESSIONAL) TURNED STIMULATION ON, THE PATIENT HAD SOME "INCREDIBLE GRIMACES", SO IT WAS TURNED OFF. BEFORE HE TURNED STIMULATION OFF, THE PATIENT WAS NOT GETTING MUCH FOR TREMOR RELIEF, AND THE TREMOR WAS WORSE ON THE RIGHT SIDE. WITH STIMULATION OFF, THE PATIENT'S TREMOR WAS NOT AS BAD AS IT WAS PRIOR TO HAVING SURGERY. IT WAS NOTED THAT THE PATIENT FELT A ZAPPING SENSATION WHEN HE RAISED HIS ARM. IT WAS ALSO REPORTED THAT IMPEDANCES WERE MEASURING GREATER THAN 4000 OHMS AND CURRENT LESS THAN "15" AMPS. THE BATTERY WAS AT 2.3 VOLTS. THE PATIENT HAD BEEN PROGRAMMED TO: C+2-1-, 2.3V, 120US, 185HZ; 6+5-, 4.2V, 120US. IMPEDANCES RUN AT 3V, 210: C0, 1 AND 2 WERE ALL 931 OHMS; C3=693 OHMS; 01, 02, 03 WERE ALL 1406 OHMS; 12=931 OHMS; 13=1406 OHMS; AND 23=931 OHMS. AN IMPEDANCE TEST AT 3.5V HAD SIMILAR RESULTS: C0, 1,2,3 WERE ALL 812 OHMS; 01=1090 OHMS; 02=1644 OHMS; 03=?; 12=1090 OHMS; 13=1090 OHMS; AND 23=812 OHMS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. WHEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    FOLLOW UP FROM THE HEALTH CARE PROVIDER REPORTED, THE CAUSE OF THE EVENT WAS END OF BATTERY LIFE. IT WAS NOTED ALL IMPEDANCES WERE NORMAL. IT WAS NOTED REPLACEMENT WAS PLANNED BUT WAS CANCELLED BY PATIENT BECAUSE A PRE-OP X-RAY REVEALED AN UNRELATED MEDICAL PROBLEM. SIGNS AND SYMPTOMS ASSOCIATED WITH THE EVENT INCLUDED TINGLING AND PARESTHESIA. IT WAS ALSO NOTED, THE UNIT TURNED OFF AND THE SYMPTOMS RESOLVED. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1