BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD HOLDER AND DEPTH STOP

    MDR report key: 2257346 · Received August 26, 2011

    Report

    Report Number
    3005677147-2011-00004
    Event Type
    Malfunction
    Date Received
    August 26, 2011
    Date of Event
    August 24, 2011
    Report Date
    August 24, 2011
    Manufacturer
    FHC, INC.
    Product Code
    HAW
    PMA / PMN Number
    K092562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESIDENT PHYSICIAN AT THE FACILITY OVER TIGHTENED THE SCREW ON THE FIXTURE, WHICH DAMAGED THE LEAD. IT WAS NOTED BY THE SURGEON PRIOR TO THE IMPLANT OF THE LEAD. A SPECIFIC WARNING IN THE DFU EXISTS FOR THIS DEVICE STATING THAT OVERTIGHTENING OF THE SCREW MAY DAMAGE THE LEAD.

    Description of Event or Problem · 1

    FHC SALES REP REPORTED OF A DAMAGED DBS LEAD DUE TO THE OVER-TIGHTENING OF THE DEPTH STOP SCREW. THERE WAS NO DELAY TO THE SURGERY SINCE A BACKUP LEAD WAS USED. THERE WAS NO PT IMPACT AS A RESULT OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD HOLDER AND DEPTH STOP NONE HAW FHC, INC. 70-CN-DB

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK MICROTARGETING STAR DRIVE SYSTEM