BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO DR

    MDR report key: 4162540 · Received October 10, 2014

    Report

    Report Number
    9614453-2014-02517
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    June 4, 2014
    Report Date
    August 7, 2014
    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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED A POWER ON RESET OCCURRED. THE ANALYST NOTED THAT A POWER ON RESET (POR) OCCURRED ON (B)(6) 2014 FOR WRITE TO LOCKED RAM.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE INDICATED A MEMORY ERROR FOR A RAM (RANDOM ACCESS MEMORY) INTEGRATED CIRCUIT.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE EXPERIENCED A POWER ON RESET (POR) DUE TO AN UNKNOWN REASON. THE DEVICE BATTERY WAS CLOSE TO ELECTIVE REPLACEMENT INDICATOR (ERI), THEREFORE THE PHYSICIAN ELECTED TO EXPLANT AND REPLACED THE DEVICE SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644144 MAXIMO DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND 7278

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R