BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECTA DR

    MDR report key: 3864932 · Received June 10, 2014

    Report

    Report Number
    9614453-2014-01483
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 30, 2014
    Report Date
    March 30, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. CONCOMITANT PRODUCT: 694765 LEAD, IMPLANTED: (B)(6) 2012.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED, ANALYZED, AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ALERT TRIGGERED DUE TO NOISE SENSED ON THE LEAD. ADDITIONALLY, IT WAS REPORTED THAT THE INDEX NOISE EPISODE WAS NOT POSSIBLE TO RETRIEVE FROM THE DIAGNOSTIC MEMORY OF THE DEVICE. THE DEVICE AND LEAD REMAIN IN USE. IT WAS NOTED THAT THE PATIENT HAS SINCE BEEN TO FOLLOW-UP AND THE ALERTS HAVE STOPPED AND NO NEW NOISE EPISODES HAVE BEEN RECORDED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339459 PROTECTA DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D364DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 4076 LEAD