BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAR ARRAY ELECTRODE INSERTION TUBE

    MDR report key: 4017948 · Received August 8, 2014

    Report

    Report Number
    3005677147-2014-00007
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    July 2, 2014
    Report Date
    August 8, 2014
    Manufacturer
    FHC, INC.
    Product Code
    HAW
    PMA / PMN Number
    K092562
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    MICROTARGETING ELECTRODES ARE SINGLE USE STERILE DEVICES USED IN MICROELECTRODE RECORDING (MER) PROCEDURES WITH A KNOWN ADVERSE EVENT OF HEMORRHAGE. IT IS A FUNCTION OF BRAIN SURGERY AND IS INHERENT TO ITS USE. THIS HEMORRHAGE IS NOT RELATED TO THE FUNCTIONAL ABILITY OF THE MT ELECTRODE USED IN THE INCIDENT.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED ON (B)(4) 2014 FROM MEDTRONIC REPRESENTATIVE. DURING THE MICROELECTRODE RECORDING PHASE OF THE STAGE 1 PROCEDURE, THE PATIENT HAD AN INTRACRANIAL HEMORRHAGE. THE EVENT WAS FIRST NOTICED AS A CHANGE IN FACIAL EXPRESSION BY THE PATIENT. UPON FURTHER INSPECTION, THE SURGEON NOTICED BLOOD COMING OUT OF THE CANNULA. THE SURGEON WENT AHEAD AND IMPLANTED THE DBS ELECTRODE AND PROMPTLY CLOSE. THE HEMORRHAGE WAS CONFIRMED ON POST-OP CT AND THE PATIENT IS STILL IN THE HOSPITAL. THE PHYSICIAN DID NOT COMPLAIN ABOUT THE PRODUCT OR REPORT A PROBLEM. THE WAS VIEWED BY THE TEAM AS ONE OF THE RISKS ASSOCIATED WITH DBS WITH MER. AS OF (B)(6) 2014, THERE HAVEN'T BEEN ANY SUBSEQUENT PROCEDURES. THE PATIENT WAS STILL AT THE HOSPITAL AT THE REHAB FACILITY. THEY ARE LOOKING AT LONG TERM REHAB FACILITY FOR THE PATIENT. NOTHING FURTHER HAS BEEN SCHEDULED OR PLANNED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466706 STAR ARRAY ELECTRODE INSERTION TUBE ELECTRODE INSERTION TUBE HAW FHC, INC. FC9001 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| S D.ZAP ARRAY INSERTION ELECTRODE STAR DRIVE| MOTOR/ENCODER