BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 3432926 · Received October 28, 2013

    Report

    Report Number
    3004209178-2013-19780
    Event Type
    Malfunction
    Date Received
    October 28, 2013
    Report Date
    October 10, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3998, LOT# V000795, IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. PRODUCT ID: 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION. IT WAS NOTED THAT THE PATIENT WALKED DOWN THE HALL AT HER HOUSE AND FELT AN ¿ELECTRICAL SHORTAGE FEELING AROUND THE IMPLANT.¿ IT WAS NOTED THAT THE PATIENT KEPT WALKING, BUT THEN HER RIGHT LEG WENT NUMB. IT WAS NOTED THAT THE PATIENT STARTED TO FALL AND WENT DOWN TO THE FLOOR AND COULD NOT GET UP. IT WAS NOTED THAT THE PATIENT ¿CRAWLED BACK TO HER BED AND PULLED HERSELF UP.¿ IT WAS NOTED THAT THE PATIENT¿S LEG WAS NUMB FOR 5 MINUTES AND THEN HER FEELING STARTED TO COME BACK TO HER RIGHT LEG. IT WAS NOTED THAT THE PATIENT ¿THOUGHT SHE MIGHT HAVE HAD A STROKE.¿ IT WAS NOTED THAT THE PATIENT CONTACTED HER HEALTH CARE PROFESSIONAL (HCP). IT WAS NOTED THAT THE PATIENT TURNED HER STIMULATION OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552295 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR