BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM III

    MDR report key: 2952946 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00158
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    October 30, 2012
    Report Date
    November 6, 2012
    Manufacturer
    MEDTRONIC S.A. (SMO)
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED AND MET EXPECTATIONS. PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. TIME OF ERI IN SAVE TO DISK ON (B)(6) 2012 DEVICE ERI<(><<)>=2.55 VOLT. WEEKLY BATTERY VOLTAGE TREND DATA SHOWS MIN B(V)=2.57 TO 2.55 VOLTS BETWEEN (B)(6) 2012. ONE-LOW BV ALERT ON (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD TRIGGERED THE ELECTIVE REPLACEMENT INDICATOR (ERI). DURING THE EXPLANT PROCEDURE, THE DEVICE HEADER BROKE INTO TWO PIECES. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57415 GEM III DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC S.A. (SMO) 7275

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R