BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STIMLOC

    MDR report key: 11870396 · Received May 24, 2021

    Report

    Report Number
    3012165443-2021-00005
    Event Type
    Malfunction
    Date Received
    May 24, 2021
    Date of Event
    May 20, 2021
    Report Date
    May 24, 2021
    Manufacturer
    QUALITY TECH SERVICES LLC
    Product Code
    GXR
    PMA / PMN Number
    K001096
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 924256, LOT#: 082211120A, PRODUCT TYPE: ACCESSORY. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 924256, SERIAL/LOT #: (B)(4), UBD: 20-APR-2023, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM MULTIPLE SOURCES (HEALTHCARE PROVIDER, FOREIGN) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT DURING THE TIGHTENING OF THE STIMLOC BASE SCREWS THE TIP OF ONE SCREW BROKE, THEREFORE IT COULD NOT BE SECURED. THE DOCTOR REQUESTED A SECOND AND THE SAME THING HAPPENED. TO SOLVE THE PROBLEM THE DOCTOR COMBINED THE TWO SCREWS THAT HAD NOT BROKEN. THE SAME SITUATION HAPPENED TO THEM IN THE RIGHT AND LEFT TREPAN. THE DOCTOR HAD TO USE A TOTAL OF FOUR STIMLOC SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765462 STIMLOC COVER, BURR HOLE GXR QUALITY TECH SERVICES LLC 924256 082211120A

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR