BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 4051830 · Received September 2, 2014

    Report

    Report Number
    3004209178-2014-16231
    Event Type
    Malfunction
    Date Received
    September 2, 2014
    Report Date
    August 4, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37742, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708340, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 3708340, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 3487A-33, LOT # J0104179V, IMPLANTED: (B)(6) 2001, PRODUCT TYPE LEAD; PRODUCT ID 3487A-33, LOT # J0104179V, IMPLANTED: (B)(6) 2001, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALTHCARE PROFESSIONAL (HCP) COULD NOT ADJUST THE PATIENT¿S STIMULATION. THE ¿CALL YOUR DOCTOR¿ ICON WAS DISPLAYED. THE ESTIMATED REPLACEMENT INDICATOR (ERI) WAS SEEN THE DAY PRIOR TO THE REPORT ON THE PATIENT PROGRAMMER. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT STARTED SEEN THE ERI MESSAGE ON HER RECHARGER ABOUT A WEEK PRIOR TO THE REPORT. THE DEVICE WAS ¿ACTING FUNNY¿ AND IT WAS ¿SHUTTING DOWN¿ BY ITSELF. THIS BEGAN OVER THE WEEKEND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532718 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR