BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MARQUIS

    MDR report key: 2964715 · Received February 15, 2013

    Report

    Report Number
    9614453-2013-00425
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    February 19, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT (B)(4) - THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THERE WAS ONE POWER ON RESET FOR WRITE TO LOCKED RAM, ADDR=0C77, DATA=89 ON (B)(4) 2012. THERE WAS ONE PATIENT ALERT FOR POWER ON REST ON (B)(4) 2012.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE HAD AN ELECTRICAL RESET. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED ASA RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68689 MARQUIS DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND 7230CX

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention