BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2821612 · Received November 6, 2012

    Report

    Report Number
    9614453-2012-00169
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 2, 2012
    Report Date
    October 10, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748951, SERIAL# (B)(4), EXPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO REPLACE AN INS FOR PREMATURE BATTERY DEPLETION (SEE MFR. REP. # 9614453-2012-00162), OUT OF RANGE IMPEDANCES WERE SEEN AFTER THE NEW INS WAS IMPLANTED. A VISUAL REVIEW DETERMINED THAT THE EXISTING EXTENSION WAS DAMAGED. THE EXTENSION WAS REMOVED AND A NEW EXTENSION WAS IMPLANTED. WHEN CONNECTING THE LEAD TO THE NEW EXTENSION IT WAS FOUND THAT ELECTRODE #8 WAS DAMAGED AND DID NOT ENTER THE EXTENSION CONNECTOR. THE HCP LEFT ELECTRODE #8 OUT OF THE EXTENSION CONNECTOR AND INSTEAD CONNECTED ELECTRODES 9, 10 AND 11 TO THE EXTENSION CONNECTOR, CORRESPONDING TO THE EXTENSION CONTACTS 8, 9, AND 10. IMPEDANCE MEASUREMENTS FOUND THAT THE THREE ELECTRODES WERE CONNECTED WELL AND THE PATIENT WAS RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR