BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROTHERM ACUTHERM DECOMPRESSION CATHETER

    MDR report key: 4337387 · Received December 8, 2014

    Report

    Report Number
    3002953813-2014-00016
    Event Type
    Injury
    Date Received
    December 8, 2014
    Report Date
    October 13, 2014
    Manufacturer
    NEUROTHERM, INC.
    Product Code
    GEI
    PMA / PMN Number
    K073466
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE SINCE THE BATCH NUMBER WAS UNAVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Description of Event or Problem · 1

    FOLLOWING AN ACUTHERM PROCEDURE PERFORMED AT L1L2, THE PATIENT DEVELOPED MUSCLE WEAKNESS IN THE RIGHT HIP AND COMPLETE FOOT DROP ON THE RIGHT FOOT; HOWEVER, SENSATION WAS INTACT. FOUR DAYS AFTER THE PROCEDURE, MOTOR FUNCTION HAS NOT IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789323 NEUROTHERM ACUTHERM DECOMPRESSION CATHETER DISPOSABLE DECOMPRESSION CATHETER GEI NEUROTHERM, INC. NT7210442

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other