BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 4844324 · Received June 15, 2015

    Report

    Report Number
    3004209178-2015-11588
    Event Type
    Malfunction
    Date Received
    June 15, 2015
    Date of Event
    May 24, 2015
    Report Date
    May 26, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT SAW A ¿CALL YOUR DOCTOR¿ ICON WITH A WARNING POWER ON RESET (POR) MESSAGE AND THEY WERE UNABLE TO ADJUST STIMULATION. THEY RECENTLY FLEW FROM (B)(6) AND WHEN THEY GOT BACK FROM THEIR TRIP THEY NOTICED THE POR. THEY DID NOT TURN THEIR DEVICE OFF WHILE TRAVELING AND IT WAS QUESTIONED IF A SECURITY CHECKPOINT COULD CAUSE THE POR. THE MANUFACTURER REPRESENTATIVE LATER RECEIVED A TEXT MESSAGE FROM THE PATIENT STATING ¿THE DEVICE ALLOWED ME TO GET IT GOING AGAIN. DON¿T NEED TO SEE A REP¿.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389019 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR