BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 7440165 · Received April 18, 2018

    Report

    Report Number
    3004209178-2018-08298
    Event Type
    Injury
    Date Received
    April 18, 2018
    Date of Event
    January 1, 2016
    Report Date
    April 18, 2018
    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

    Additional Manufacturer Narrative · 1

    CORRECTION TO SHOW INFORMATION NOT ADDED IN THE ORIGINAL REGULATORY REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PATIENT SAID ALREADY IT SEEMED TO BE TAKING LONGER TO CHARGE THE BATTERY, AND IT SEEMED TO RUN OUT OF JUICE FASTER. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR PARKINSON¿S DUAL, MOVEMENT DISORDERS. IT WAS REPORTED THAT THE REP WOULD BE MEETING WITH THE PATIENT DAY OF THE CALL. THE CALLER REPORTED THAT THE PATIENT¿S INS HAD BEEN TURNING OFF BY ITSELF. PATIENT STARTED HAVING ISSUES WITH WALKING,THAT THEY HAD TO CRAW SINCE AT TIMES SINCE (B)(6) 2017. IMPEDANCE CHECK ON THE LEFT IMPLANT SHOWED IMPEDANCE OF 700-1100 OHMS. LEFT 8+ 9- 10-, RIGHT 2+ 1- 0-. BOTH SIDES AT 7 VOLTS 60USEC AND 150 HZ, THERAPY IMPEDANCE WAS 539 (LEFT) OHMS AND (RIGHT) 1012 OHMS. ELECTRODE IMPEDANCE FOR THE RIGHT SIDE: RIGHT C0 3500 OHMS C1 870 C2 848 C3 896 01 3012 02 3745 03 3906 12 1036 13 1260 23 1021 OHMS DISCUSSED ELECTRODE 0 BEING A LITTLE HIGH AND THAT ELECTRODE WAS USED IN PROGRAMMING. DISCUSSED POTENTIAL CONNECTION ISSUE PATIENT TO LOSE THERAPY. PATIENT DIDN¿T RECALL ANY TRAUMA. IT WAS REVIEWED IT WAS UP TO THE HCP TO IF SURGERY NECESSARY IF PROGRAMMING DIDN¿T RESOLVE ISSUE. RECHARGE INTERVAL WAS LOW AT 5.97 DAYS, EMPTY 7.96 DAYS. PATIENT SAID THEIR RECHARGE OF A FULL INS COULD LAST ABOUT 4 DAYS, THUS BATTERY POWER WAS NOT AN ISSUE. WHEN PATIENT FELT THERAPY WAS NOT WORKING PP SHOWED IMPLANT WAS ON. THE PATIENT HAD MENTIONED THAT THEIR DEVICE MALFUNCTIONED, STOPPED WORKING, AND WERE CARRIED TO THE ER. A NEUROSURGEON (INEXPERIENCED WITH DBS) REMOVED THE BATTERY, WASHED IT, AND REINSTALLED IT AND IT RESUMED NORMAL FUNCTIONING. IN 2016 THE PATIENT MOVED TO (B)(6) AND HAD A FALL. (B)(6) 2017/2018 THE DBS STOPPED FUNCTIONING, IMMOBILITY LASTED 24 HOURS, THEN RESUMED FUNCTION. PATIENT WAS CURIOUS HOW MUCH LIFE THEIR BATTERY HAD. PATIENT WAS TOLD IT WOULD LAST 9 YEARS, WHICH WOULD PUT THEM AT 2-3 MORE YEARS, BUT THEIR SETTINGS WERE HIGH AND WONDERED IF THAT WOULD BRING EOS MORE QUICKLY. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283307 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention