BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3795799 · Received May 7, 2014

    Report

    Report Number
    3004209178-2014-08625
    Event Type
    Malfunction
    Date Received
    May 7, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 11, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3487A-33, LOT# V160153, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37082-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3487A-33, LOT# V152707, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SAW AN END OF SERVICE (EOS) OR END OF LIFE (EOL) MESSAGE. IT WAS NOTED THAT THE PATIENT WENT TO THE DOCTOR TO GET THE IMPLANTABLE NEUROSTIMULATOR (INS) JUMP STARTED. IT WAS NOTED THAT THE INS WAS TOO LOW TO CHARGE ON ITS OWN. IT WAS NOTED THAT THE PATIENT STATED THAT HE WAS ABLE TO GET IT BACK UP AND CHARGING BUT NOW THE PROGRAMMER WAS SHOWING EOS. IT WAS NOTED THAT THE PATIENT COULDN¿T GET IT TO DO ANYTHING ELSE. IT WAS NOTED THAT THE PATIENT STATED THAT HE WAS IN OVERDISCHARGE 1 OTHER TIME A LITTLE OVER A YEAR AGO. IT WAS NOTED THAT THE PATIENT¿S INS WAS IN FACT IN EOS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276397 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 00042 YR