BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD, UNKNOWN

    MDR report key: 3970889 · Received July 31, 2014

    Report

    Report Number
    3007566237-2014-02136
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 924256, LOT# 082200814A, IMPLANTED: 2014-(B)(6), EXPLANTED: 2014-(B)(6), PRODUCT TYPE ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE HEALTHCARE PROFESSIONAL (HCP) DRILLED THE BUR HOLE AND SCREWED IN THE STIMLOC, BUT THE STIMLOC DID NOT CLICK INTO PLACE. THE REPORTER STATED THE HCP CHECKED THE CLICK FOR THE SLIDE ATTACHMENT. IT WAS NOTED THE PATIENT TRIED THE STIMLOC IN A FEW DIFFERENT ORIENTATIONS IN THE BUR HOLE, BUT THE ATTACHMENT WOULD NOT CLICK INTO PLACE. IT WAS FURTHER NOTED THE HCP CHECKED THE SLIDE ON THE STERILE TABLE AND THE SLIDE DID NOT CLICK AND HOLD INTO PLACE EITHER. THE REPORTER STATED ANOTHER STIMLOC WAS OPENED AND THAT ATTACHMENT WORKED PERFECTLY. IT WAS NOTED THAT THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS DOING WELL AND THEY WERE RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448472 LEAD, UNKNOWN STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_UNKNOWN_LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1