BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN NEUROSTIMULATOR

    MDR report key: 4130011 · Received September 30, 2014

    Report

    Report Number
    3007566237-2014-02781
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    September 8, 2014
    Report Date
    October 4, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 3708660, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION; PRODUCT ID NEU_UNKNOWN_LEAD, LOT # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_PTM_PROG, SERIAL # UNKNOWN, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A SHORT DURING A STAGE 2 UNILATERAL IMPLANT PROCEDURE. AFTER THEY CONNECTED THE EXTENSION TO THE LEAD AND THE BATTERY TO THE EXTENSION THERE WAS A SHORT. THERE WAS LOW IMPEDANCE OF 32 OHMS ON BIPOLAR ELECTRODES 1 AND 2. THE DOCTOR DIDN¿T REOPEN OR CHECK ANY CONNECTION AND THEY WERE GOING TO SEE IF THE NEUROLOGIST COULD PROGRAM AROUND IT. THE ISSUE WAS NOT RESOLVED AND THE PATIENT STATUS AT THE TIME OF REPORT WAS ALIVE WITH NO INJURY AND NO SYMPTOMS REPORTED. ALL MONO-POLAR IMPEDANCES WERE NORMAL AND THE SURGEON DID NOT REOPEN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609177 UNKNOWN NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR