BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2978565 · Received February 26, 2013

    Report

    Report Number
    3007566237-2013-00597
    Event Type
    Injury
    Date Received
    February 26, 2013
    Report Date
    August 26, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    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

    ANALYSIS OF THE EXTENSIONS (SERIAL (B)(4)) FOUND THAT BOTH OF THE OUTER INSULATIONS WERE TWISTED. ALL THE CONDUCTORS WERE SEVERELY STRETCHED. SHORTS WERE OBSERVED ON CIRCUITS #1, 2 AND 3 DUE TO THE OVERSTRESS/DAMAGE OF THE CONDUCTORS. THE OUTER INSULATION WAS SEVERELY TWISTED. (B)(6).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: 2010-01-01 EXPLANTED: PRODUCT TYPE EXTENSION PRODUCT ID 37085-60 LOT# SERIAL# NKN003882V IMPLANTED: EXPLANTED: PRODUCT TYPE EXTENSION PRODUCT ID 3389 LOT# SERIAL# UNKNOWN IMPLANTED: 2010-01-01 EXPLANTED: PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT FELT FINE IMMEDIATELY AFTER THE REVISION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A SHOCKING SENSATION NEAR THE POCKET OF THE IMPLANTABLE NEUROSTIMULATOR (INS). LOW IMPEDANCES WERE MEASURED. THE RIGHT ONE WAS BETWEEN 220-600 OHMS AND THE LEFT SIDE WAS 31 OHMS. IT WAS STATED THAT THE EXTENSION WAS 'FRAYED.' NO FURTHER INFORMATION WAS PROVIDED ABOUT THE CONDITION OF THE EXTENSION. X-RAYS WERE TAKEN IN ADDITION TO IMPEDANCE TESTING. IT WAS NOTED THAT AN EXPLANT WAS PLANNED, BUT NO DATE WAS GIVEN. IT WAS STATED THAT THE PATIENT WAS ALIVE WITH INJURY AND THAT THEY REQUIRED HOSPITALIZATION. FURTHER INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82744 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R