BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2928931 · Received January 24, 2013

    Report

    Report Number
    3004209178-2013-00948
    Event Type
    Malfunction
    Date Received
    January 24, 2013
    Report Date
    January 7, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7482A40, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A40, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 64002, LOT # N334240, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ADAPTER; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3389S-40, LOT # V092655, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3389S-40, LOT # V091844, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN OPEN CIRCUIT IN HER SYSTEM (SEE MFR. REP. # 3004209178-2012-03701). THE INS AND POCKET ADAPTOR WERE REMOVED IN (B)(6) 2012 DUE TO NORMAL BATTERY DEPLETION, BUT IT WAS REPORTED THAT CHANGING OUT THE INS AND ADAPTOR STILL DID NOT FIX THE IMPEDANCE ISSUE. IT WAS NOTED THAT THE EXTENSION WAS NOT CHANGED OUT AT THAT TIME AS THE PATIENT WOULDN'T HAVE LIKED THAT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT DURING THE REPLACEMENT PROCEDURE, THE ADAPTOR WAS REPLACED WITHOUT CORRECTION OF THE OPEN CIRCUIT ON THE "LEFT" ELECTRODES "2/3". NO HOSPITALIZATION WAS REPORTED AND THE PATIENT WAS REPORTED AS DOING WELL WITH CURRENT SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33491 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1