BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH STOP ADAPTER

    MDR report key: 1659134 · Received April 13, 2010

    Report

    Report Number
    3005677147-2010-00002
    Event Type
    Malfunction
    Date Received
    April 13, 2010
    Date of Event
    March 9, 2010
    Report Date
    March 9, 2010
    Manufacturer
    FHC, INC.
    Product Code
    HAW
    PMA / PMN Number
    K092562
    Removal / Correction Number
    3005677147-4/09/10-002-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE PRODUCT WAS PERFORMED BY FHC TECH SUPPORT PERSONNEL AT THE SURGERY. THIS EVALUATION FOUND THAT THE SCREW USED TO FIXATE THE LEAD WITHIN THE DBS DEPTH STOP ADAPTER HAD DAMAGED THE LEAD. THIS WAS A VALIDATION CASE FOR A RECENT PRODUCT IMPROVEMENT TO THE DEPTH STOP ADAPTER. A SPECIFIC WARNING IN THE DFU EXISTS FOR THIS DEVICE STATING THAT OVERTIGHTENING OF THE SCREW MAY DAMAGE THE LEAD. IMPROVEMENT WAS ALSO INSTALLED ON OTHER DEPTH STOP ADAPTERS. SUBSEQUENT FIELD ACTION IS UNDERWAY FOR THIS PRODUCT.

    Description of Event or Problem · 1

    TECH SUPPORT PERSONNEL ATTENDED A SURGERY WITH THE STAR DRIVE SYSTEM IN USE FOR PLACEMENT OF A DBS LEAD. SURGEON WAS VALIDATING AN IMPROVEMENT TO THE DEPTH STOP ADAPTER. THE DEPTH STOP ADAPTER USED TO HOLD THE DBS LEAD PRIOR TO PLACEMENT DAMAGED THE LEAD - THERE WAS A SHORT BETWEEN TWO OF THE LEAD CONTACTS. THIS WAS NOTED PRIOR TO LEAD PLACEMENT. A NEW LEAD WAS USED AND PLACED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPTH STOP ADAPTER HAW FHC, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 STAR DRIVE SYSTEM