BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 2870138 · Received December 12, 2012

    Report

    Report Number
    3007566237-2012-02993
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Report Date
    November 16, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALTHCARE PROVIDER (HCP) HAD SEEN "BREAKS ON LEAD MANY TIMES." THE HCP STATED THIS OCCURRED "OFTEN." IT WAS ALSO STATED THAT THIS HAPPENED WHEN "THEY MOVED THEIR NECK BACK AND FORTH AND IT STRAINED THE LEAD." IT WAS UNCLEAR IF THE HCP WAS REFERRING TO A PARTICULAR PATIENT OR THEIR PATIENTS IN GENERAL WITH THIS INFORMATION. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT A DOCTOR HAD ONE DOCUMENTED LEAD BREAK IN THE RECENT PAST [SEE MFR. REPORT # 300420917 8-2012-11406] AND A LEAD BREAK IN THE REGION MENTIONED WAS A COMMON EXPERIENCE. IT WAS REPORTED THAT THE BREAK WAS LIKELY DUE TO HEAD ROTATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1