BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3050171 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05854
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    May 9, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE EXTENSION, MODEL # 3708660, SN (B)(4), FOUND THAT THE ADHESIVE JOINT WAS BROKEN BETWEEN THE OUTER TUBE AND THE #2 CONNECTOR SLEEVE. ALSO, THE EPOXY FILLER WAS FOUND TO BE BROKEN AT THE #3 WIRE (OPEN CIRCUIT DUE TO BREAK).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: EXTENSION: PRODUCT ID 3389S-40, LOT# VA05SEK, IMPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN EXTENSION WAS TUNNELED IN A NORMAL FASHION AND HOOKED UP TO A LEAD AND IMPLANTABLE NEUROSTIMULATOR (INS) AND THERE WERE HIGH IMPEDANCES ON CONTACT THREE. THE EXTENSION WAS DISCONNECTED, THE LEAD WAS INSPECTED, AND IMPEDANCES WERE RUN AGAIN. IT WAS REPORTED THAT THE HIGH IMPEDANCE ON CONTACT THREE PERSISTED. A NEW EXTENSION WAS HOOKED UP AND IMPEDANCES WERE NORMAL WITH THE NEW EXTENSION. IT WAS NOTED THAT THERE WAS BREAKAGE ON THE FIRST EXTENSION. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149667 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR