BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAR DRIVE

    MDR report key: 8946872 · Received August 29, 2019

    Report

    Report Number
    3002250546-2019-00004
    Event Type
    Malfunction
    Date Received
    August 29, 2019
    Date of Event
    April 17, 2019
    Report Date
    August 29, 2019
    Manufacturer
    FHC, INC,
    Product Code
    HAW
    UDI-DI
    00873263001486
    PMA / PMN Number
    K092562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS ORIGINALLY SUBMITTED ON 05/20/19 BUT DUE TO A TECHNICAL ERROR, IT DID NOT UPLOAD.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM MEDTRONIC - DISTRIBUTOR OF PRODUCT, REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT DURING IMPLANT OF THE PATIENT'S RIGHT LEAD, THE STARDRIVE TOWER WAS NOT ATTACHED TO THE STARDRIVE BODY TO HOLD THE DBS LEAD AT THE CORRECT TARGET. AS A RESULT, THE DEPTH STOP WAS PLACED ON THE DRIVE INCORRECTLY AND THE LEAD TRAVELED DEEPER THAN DESIRED. THE ERROR WAS DISCOVERED AND THE LEAD WAS PLACED ON THE TOWER CORRECTLY AND THE LEAD LOCATION WAS CONFIRMED CORRECT WITH A CT SCAN. IT WAS NOTED THE SURGICAL TEAM WAS INEXPERIENCED AND MISSED A STEP TO PLACE THE TOWER ON THE STARDRIVE. THE REP ALSO NOTED THEY THEMSELVES FAILED TO RECOGNIZE THE STEP WAS MISSED. THE ISSUE WAS RESOLVED. IT WAS NOTED THE PATIENT EXPERIENCED RIGHT EYE SIX NERVE PALSY; THEIR RECOVERY WAS TO BE MONITORED OVER THE NEXT SIX MONTHS. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    740705 STAR DRIVE STEREOTAXIC INSTRUMENT HAW FHC, INC, FC8001 00873263001486

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other