BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN NEUROSTIMULATOR

    MDR report key: 4132520 · Received October 1, 2014

    Report

    Report Number
    3007566237-2014-02794
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Report Date
    September 9, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3389S-40, LOT# V497075, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 37085-95, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION; PRODUCT ID 3389S-40, LOT# V497075, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 37085-95, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE MANUFACTURER REPRESENTATIVE HAD NEVER MET WITH THE PATIENT. THE PATIENT WAS TOLD TO MEET UP WITH THEIR NEUROLOGIST ASAP TO REVIEW HIS OPTIONS. THEY WERE UNWILLING TO GO BACK TO SURGERY AT THE TIME OF REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS AN IMPEDANCE ISSUE OF UNKNOWN VALUE ON ELECTRODES 9 AND 11. IT WAS NOTED THE PATIENT HAD THEIR BATTERY CHANGED IN (B)(6) AND TWO ELECTRODES SHORTED AFTER THE CASE. SINCE THEN THE DOCTOR COULDN¿T PROGRAM AROUND THE SHORTS AND HAD TURNED THE DEEP BRAIN STIMULATOR (DBS) OFF. THE PATIENT STATUS AT THE TIME OF REPORT WAS ALIVE WITH NO INJURY AND THEY HAD A LESS THAN 50% THERAPY RELIEF. THE DBS WAS OFF SO THE PATIENT COULDN¿T FUNCTION. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611333 UNKNOWN NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1