BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3203586 · Received July 3, 2013

    Report

    Report Number
    3007566237-2013-02195
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 10, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3389-28, LOT# 0205741332, IMPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 37085-60, SERIAL# UNKNOWN, IMPLANTED: 2012-(B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    WHEN THE PHYSICIAN WAS CONTACTED FOR FOLLOW UP INFORMATION, NO INFORMATION WAS ABLE TO BE OBTAINED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE LOW IMPEDANCES ON ¿PIN¿ 9 AND 10, REPORTED TO BE 60 OHMS. IT WAS STATED THIS OCCURRED WHEN ¿THE STIM ULATION SHOULD BE REVISED UPWARDS.¿ LESS THAN 50% THERAPY RELIEF WAS NOTED. INTRAOPERATIVELY, OVER 4 VOLTS, THERE WERE JOLTING SENSATIONS IN THE RIGHT ARM AND LEG. THERE WAS ALSO AN OUT OF REGULATION (OOR) ERROR. REPROGRAMMING WAS DONE. IT WAS NOTED THAT FURTHER SURGERY WOULD BE NEEDED, BUT THE PATIENT WANTED TO WAIT UNTIL FALL.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE HEALTHCARE PROVIDER (HCP) DID NOT BELIEVE THE PROBLEM WAS DUE TO THE IMPLANTS. THE PATIENT WAS DIFFICULT TO ASSESS AND HAD A MENTAL ILLNESS. THE STIMULATOR WAS ¿AGAIN SWITCHED TO A PAGE WITH GOOD SUCCESS.¿ THE HCP DID NOT RESPOND ¿BEFORE THE PATIENT TO OPERATE.¿ IT WAS UNCLEAR WHAT THIS MEANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305156 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention