BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEM III

    MDR report key: 3152023 · Received June 7, 2013

    Report

    Report Number
    9614453-2013-01083
    Event Type
    Injury
    Date Received
    June 7, 2013
    Report Date
    March 21, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    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. PRODUCT EVENT SUMMARY: PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. THE TIME OF ELECTIVE REPLACEMENT INDICATOR (ERI) IN SAVE TO DISK WAS (B)(6) 2013, WITH A VOLTAGE OF LESS THAN OR EQUAL TO 2.55 VOLTS ON THE DEVICE. THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)  REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) EARLIER THAN EXPECTED. THE ICD 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
    253053 GEM III DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND 7231CX

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 6947 IMPLANTABLE TACHY LEAD