BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECIFY

    MDR report key: 3870729 · Received June 12, 2014

    Report

    Report Number
    6000153-2014-00119
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Report Date
    May 20, 2014
    Manufacturer
    NEURO - VILLALBA
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37083-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT LEG PAIN WAS COVERED BY AN IMPLANTABLE NEUROSTIMULATOR (INS) FROM A DIFFERENT MANUFACTURER CONNECTED TO THE DEVICE IN THIS REPORT. FOR ABOUT 6 WEEKS, THE PATIENT SUDDENLY FELT HIGH FREQUENCY STIMULATION FROM THAT INS IN THE FOOT. IT WAS REPORTEDLY AN OVERSTIMULATION SENSATION. IMPEDANCE TESTING SHOWED ALL IMPEDANCES WERE WITHIN NORMAL LIMITS. THE INS WAS REPROGRAMMED SO THE PATIENT DIDN¿T FEEL THE HIGH FREQUENCY STIMULATION. THE INS WAS SWITCHED OFF APPROXIMATELY TWO WEEKS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348866 SPECIFY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW NEURO - VILLALBA 39286-30 0206497959

    Patients

    Seq Age Sex Outcome Treatment
    1