BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3308766 · Received August 26, 2013

    Report

    Report Number
    3004209178-2013-15179
    Event Type
    Malfunction
    Date Received
    August 26, 2013
    Report Date
    August 1, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3550-39 LOT# N231449, IMPLANTED: 2009 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 37743, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3778-45, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37752, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 37743, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37752, SERIAL# (B)(4); PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT PROGRAMMER AND RECHARGER HAVE NOT READ THE SAME FOR ABOUT TWO YEARS. IT WAS NOTED, THE PATIENT PROGRAMMER SHOWED THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS FINE AND CHARGED. THE REPORTER STATED THEY WENT TO THE MALL AND FELT LIKE THE INS WAS COMPLETELY OFF AND THEY WERE SCARED BECAUSE THEY REMEMBER WHAT THEIR PAIN WAS LIKE BEFORE AND DON¿T WANT TO EXPERIENCE THAT AGAIN. IT WAS NOTED, THE PATIENT CONTACTED A MANUFACTURING REPRESENTATIVE WHO TOLD THE PATIENT TO RECHARGE THEIR INS. IT WAS NOTED THE RECHARGER ONLY SHOWED ¿A SHADOW¿ WHEN THEY RECHARGED. THE REPORTER STATED, THE PATIENT PROGRAMMER SHOWED THE INS WAS AT LEAST 25% CHARGED AND THE RECHARGER SHOWED THE INS WAS CHARGING AT 25-50%. IT WAS NOTED THE PATIENT TRIED THE INS AND IT TOOK THEIR PAIN AWAY INSTANTLY. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416792 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 00058 YR