BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3232790 · Received July 18, 2013

    Report

    Report Number
    3004209178-2013-11935
    Event Type
    Malfunction
    Date Received
    July 18, 2013
    Report Date
    December 7, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389-40, LOT# J0306952V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: LEAD. PRODUCT ID: 3389-40, LOT# J0443883V, IMPLANTED: (B)(6) 2004, PRODUCT TYPE: LEAD. PRODUCT ID: 37092, LOT# 286830001, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ELECTIVE REPLACEMENT INDICATOR (ERI) WAS PRESENT ON THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT THE DEPLETION WAS NORMAL, AND THE BATTERY WAS ABOUT TO BE REPLACED. IT WAS ALSO REPORTED THAT 2 WEEKS PRIOR TO (B)(6) 2012 THE PATIENT FELL. FOLLOWING THE FALL THERE WERE NO DISCERNIBLE CHANGES IN THE PATIENT¿S SYMPTOM CONTROL/THERAPY. IT WAS NOTED; HOWEVER, THAT ELECTRODE 3 HAD A HIGH MONOPOLE IMPEDANCE. THE ELECTRODE WAS ABLE TO BE PROGRAMMED AROUND BY USING ANOTHER ELECTRODE AND INCREASING THE PROGRAMMED PULSE WIDTH. IT WAS LATER REPORTED THAT SINCE THE PATIENT WAS RECEIVING EFFECTIVE THERAPY, ONLY THE BATTERY WAS REPLACED. THE PATIENT WAS RECEIVING EFFECTIVE THERAPY IN THE RECOVERY ROOM AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333022 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR