BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ADVANCED

    MDR report key: 3608461 · Received February 5, 2014

    Report

    Report Number
    3004209178-2014-01595
    Event Type
    Malfunction
    Date Received
    February 5, 2014
    Report Date
    January 14, 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

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 377760, LOT# V015438, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 377760, LOT# V016552, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A PROBLEM WITH THE INS SUSPECTED. IT WAS NOTED THERE WAS AN EOS/EOL MESSAGE. IT WAS LOGGED THE PATIENT WAS SEEING A "POS" MESSAGE. IT WAS NOTED THERE IS NO POS MESSAGE THAT THE PATIENT LIKELY WAS AT EOS. IT WAS REPORTED THIS WAS A RECHARGEABLE DEVICE AND IT HAD ONLY BEEN LESS THAN 7 YEARS, BUT THE PATIENT HAD HAD OVER-DISCHARGES BEFORE AND SHE WAS COMING OUT OF AN OVER-DISCHARGE SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74121 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