BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3606174 · Received February 4, 2014

    Report

    Report Number
    3004209178-2014-01549
    Event Type
    Malfunction
    Date Received
    February 4, 2014
    Report Date
    January 30, 2014
    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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37743, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3998, LOT# V163064, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37752, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ¿AFRAID THAT HER IMPLANTABLE NEUROSTIMULATOR WAS IN OVERDISCHARGE.¿ IT WAS NOTED THAT THE PATIENT WAS UNABLE TO COMMUNICATE WITH THE PATIENT PROGRAMMER OR THE RECHARGER. IT WAS NOTED THAT THE PATIENT HAD LOST SOME WEIGHT. IT WAS FURTHER NOTED THAT AN INS OVERDISCHARGE WAS SUSPECTED. IT WAS NOTED THAT THE LAST TIME STIMULATION WAS FELT WAS 3 TO 5 WEEKS PRIOR TO THE REPORT. THE LAST SUCCESSFUL RECHARGING SESSION WAS OVER 30 DAYS PRIOR TO THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72948 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 00051 YR