BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 7399351 · Received April 5, 2018

    Report

    Report Number
    3004209178-2018-06535
    Event Type
    Malfunction
    Date Received
    April 5, 2018
    Date of Event
    November 27, 2017
    Report Date
    April 5, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529762
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS. IT WAS REPORTED THAT THE PATIENT HAS HIGH IMPEDANCE ACROSS MOST OF THE ELECTRODES ON LEFT SIDE. C 0 = 15130 C 1 = 792 C 2 = 13438 C3 = 852 0 1 = 15130 02 = 33712 0 3 = 15582 12 =13555 23 = 13674 13 = 1225 THERAPY IMPEDANCE AS OF YESTERDAY WAS 1200 OHMS. THE PATIENT HAS NOT HAD THERAPY CHANGES SINCE THE INS WAS PLACED IN (B)(6) 2017. PATIENT HAS BEEN PROGRAMMED TO 0+1+2-3- FOR A WHILE, AT LEAST SINCE 2011 PER CALLER. HISTORICAL THERAPY IMPEDANCE SHOW A GRADUAL RISE IN THE THERAPY Z RECENTLY: 2011 =930 OHMS ;2014 = 645 OHMS; 2015 = 690 OHMS; (B)(6) 2016 = 687 OHMS; (B)(6) 2016 = 1034 OHMS; (B)(6) 2017 = 1178 OHMS. THE FOLLOWING TROUBLESHOOTING STEPS WERE REVIEWED TO THE CALLER: TAKE IMPEDANCES IN VARIOUS ROM OR POSITIONS AND DISCUSS X-RAY/FLUOROSCOPY. THERE IS NO OTHER HISTORY OF ELECTRODE IMPEDANCE AS THE CALLER SAYS THEY ONLY TEND TO DO THERAPY IMPEDANCE CHECKS. PATIENT IS NOT HAVING ANY INTERMITTENCY OF THERAPY, SHOCKING OR ANY OTHER SYMPTOMS AT THIS TIME AND IT WAS REVIEWED TO TRY AND PROGRAM JUST 1 AND 3 TO SEE IF THE PATIENT STILL GETS BENEFIT SINCE THEY ARE NORMAL IMPEDANCE PAIR. NO SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242779 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612 00643169529762

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR