BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2070128 · Received April 21, 2011

    Report

    Report Number
    9614453-2011-02998
    Event Type
    Injury
    Date Received
    April 21, 2011
    Date of Event
    April 4, 2011
    Report Date
    April 4, 2011
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    RECEIVED INFO, THE PT PROGRAMMER DISPLAYED THE ELECTIVE REPLACEMENT INDICATOR AND A SHORT TIME AFTER THIS THE END OF SERVICE INDICATOR AND STIMULATION STOPPED. THE PHYSICIAN TRIED TO INTERROGATE THE INS BUT HE GOT THE "EOS WARNING AND WAS NOT ABLE TO REPROGRAM. THE PROGRAMMED SETTINGS WERE: 4 ACTIVE ELECTRODES, TWO POSITIVE AND TWO NEGATIVE, ONE GROUP, ONE PROGRAM, AMPLITUDE 7V, PULSE WIDTH 300 US, FREQUENCY 60 HZ. IMPEDANCES AFTER IMPLANT WERE NORMAL, NO SHORTS. CALCULATED BATTERY LIFETIME WAS 6 MONTHS. THE REPLACEMENT FOR THE INS WAS SCHEDULED FOR (B)(6) 2011. NO INJURY REPORTED AT THIS TIME. ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, A FOLLOW UP WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MEDTRONIC EUROPE SARL 37702 S100258

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention