BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 8146821 · Received December 10, 2018

    Report

    Report Number
    3007566237-2018-03549
    Event Type
    Injury
    Date Received
    December 10, 2018
    Report Date
    December 10, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3389-28, LOT #: UNKNOWN, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR PARKINSON'S DISEASE. IT WAS REPORTED THAT THE PATIENT'S LEAD DEVIATED 20MM DEEPER THAN THE TARGET POSITION DUE TO LEAD DISLOCATION WHICH OCCURRED DURING DAILY LIFE. THE ORIGINAL PROCEDURE HAD GREAT ISSUE. WHEN THE IMPLANTATION WAS PERFORMED IN THE OLD DAYS, THE BURR HOLE CAP WAS NOT USED; FIXATION WAS PERFORMED USING BONE CEMENT. AS A RESULT, INADEQUATE FIXATION WAS CONSIDERED TO BE CAUSED. REOPERATION WAS PERFORMED, AND THE LEAD WAS PULLED UP WHILE TAKING X-RAY IMAGES. THE SKULL WAS FIXED WITH A PLATE. THE DEVICE REMAINED IMPLANTED AND THE ISSUE WAS CONSIDERED RESOLVED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985697 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention