BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3891784 · Received June 24, 2014

    Report

    Report Number
    3007566237-2014-01757
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Report Date
    June 13, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37742, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT FELT GOOD ¿FOR A BIT¿ WHEN PROGRAMMING CHANGES WERE MADE AND THAT ¿A FEW MONTHS DOWN THE ROAD HE FELT CRAPPY AGAIN.¿ IT WAS NOTED THAT ONE OF THE PATIENT¿S LEADS HAD BEEN SHUT OFF AT THE TIME OF REPORT. ADDITIONAL INFORMATION WAS REQUESTED; A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    PLEASE NOTE THAT ALL INFORMATION PREVIOUSLY REPORTED UNDER THIS REGULATORY REPORT WAS REPORTED IN ERROR AND ACTUALLY PERTAINED TO A NON-NEUROSTIMULATORY SYSTEM. THERE IS NO INDICATION AT THIS TIME THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) HAD POTENTIALLY MALFUNCTIONED AS WAS INITIALLY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367626 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1