BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 6226130 · Received January 5, 2017

    Report

    Report Number
    3004209178-2017-00287
    Event Type
    Malfunction
    Date Received
    January 5, 2017
    Date of Event
    December 5, 2016
    Report Date
    January 5, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CONSUMER IMPLANTED FOR COMPLEX REGIONAL PAIN SYNDROME TYPE II AND SPINAL PAIN REPORTED THAT AFTER THE WEATHER GOT COLD THEY ¿FELT A ZING LIKE LICKING A BATTERY WHEN STIMULATION WAS ON.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8061 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR