BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3902937 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-12290
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Report Date
    June 6, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE RECHARGER PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE MANUFACTURING REPRESENTATIVE WAS NOT SURE THE PATIENT ACTUALLY HAD AN MRI.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A THORACIC MRI BACK IN APRIL AND, SINCE THEN, HAD ¿DIFFICULTY CHARGING¿ THEIR IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS ALSO NOTED THAT THE PATIENT¿S INS WAS NOW IN AN OVERDISCHARGE CONDITION. THE MANUFACTURER¿S REPRESENTATIVE WAS GOING TO MEET WITH THE PATIENT NEXT TO EVALUATE THEIR INS SYSTEM. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379701 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR