BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3472940 · Received November 15, 2013

    Report

    Report Number
    3004209178-2013-20936
    Event Type
    Malfunction
    Date Received
    November 15, 2013
    Report Date
    October 23, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 399930, LOT# V022881, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: RECHARGER. PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE INS MIGHT HAVE BEEN FLIPPED. IT WAS REPORTED THE PATIENT¿S ¿BATTERY FELL OVER INSIDE HER¿ THE MONTH PRIOR TO REPORT. IT WAS NOTED IT WAS STARTING TO BOTHER THE PATIENT. IT WAS LOGGED IT FELT LIKE IT WAS MOVING AROUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594900 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR