BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

    MDR report key: 6088952 · Received November 9, 2016

    Report

    Report Number
    3007566237-2016-03970
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Report Date
    November 9, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITNAT MEDICAL PRODUCTS: PRODUCT ID 3389-40, LOT# 0207109754, PRODUCT TYPE: LEAD. PRODUCT ID 3389-28, LOT# VA152E2, PRODUCT TYPE: LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A HEALTHCARE PROFESSIONAL, VIA A MANUFACTURER REPRESENTATIVE, REPORTED LEAD DAMAGE WHEN REMOVING THE STYLET HANDLE DURING A PROCEDURE. WHEN REMOVING THE STYLET HANDLE FROM THE DEEP BRAIN STIMULATION (DBS) LEAD, THE PROXIMAL END OF THE DBS LEAD KINKED. SUBSEQUENTLY, IT WAS DIFFICULT TO INSERT THE DBS LEAD INTO THE EXTENSION CABLE DUE TO DAMAGE ON THE PROXIMAL END. IMPEDANCE MEASUREMENTS WERE TAKEN BY THE PHYSICIAN DURING THE PROCEDURE. HIGHER THAN USUAL IMPEDANCES WAS SUSPECTED ON AT LEAST ONE OF THE CONTACTS ON THE DBS LEAD. NO KNOWN EVENTS MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. NO KNOWN INTERVENTIONS WERE TAKEN TO RESOLVE THE ISSUE. FOLLOW UP INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) VIA THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT, FOR CASE 1, EXTENSIVE IMPEDANCE MEASUREMENTS WERE PERFORMED POST-OPERATIVELY TO TROUBLESHOOT THE ISSUE. ABNORMAL, LOW, IMPEDANCES WERE MEASURED FOR CONTACTS 0 AND 1, SUGGESTING A SHORT BETWEEN THOSE CONTACTS. THE RESOLVE THE ISSUE CONTACTS 0 AND 1 WERE TAKEN INTO ACCOUNT WHEN PERFORMING PROGRAMMING/SETTINGS. FOR CASE 2, IMPEDANCE MEASUREMENTS WERE ALSO TAKEN POST-OPERATIVELY AND ABNORMAL, HIGH, IMPEDANCES WERE OBSERVED FOR CONTACT 8. HOWEVER, IT WAS CONCLUDED THAT CONTACT 8 WAS NOT NEEDED FOR THERAPEUTIC STIMULATION SO NO FURTHER CONSEQUENCES OR ACTIONS WERE TAKEN TO RESOLVE THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739225 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1