BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOOM

    MDR report key: 3912541 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-13263
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    EXTERNAL MANUFACTURER
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE PROGRAMMER UNDERWENT VISUAL AND FUNCTIONAL TESTING. THE PROGRAMMER WAS POWERED ON TO CHECK FOR ERROR REPORTS OR BOOT-UP ISSUES. ANALYSIS FOUND THAT THERE WAS AN ISSUE WITH A PORTION OF THE CIRCUITRY RELATED TO THE PROGRAMMER SCREEN AND THERE WAS EVIDENCE OF OVERHEATING. THERE WERE PARTS THAT WERE FOUND TO HAVE BEEN DAMAGED AND FRACTURED, WHICH WAS CAUSED BY MISHANDLING OR ABUSED. THE COMPONENTS WERE THEN REPLACED, AND THE PROGRAMMER THEN PASSED THROUGHOUT ALL TESTS. LABORATORY ANALYSIS CONFIRMED THE REPORTED CLINICAL OBSERVATIONS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS RETURNED WITH NO REPORTED PRODUCT PERFORMANCE ISSUES AND NO REPORTED ADVERSE PATIENT EFFECTS. INITIAL ANALYSIS COMPLETED IN OUR POST MARKET QUALITY ASSURANCE LABORATORY IDENTIFIED A PRODUCT PERFORMANCE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389689 ZOOM LWS EXTERNAL MANUFACTURER 3120

    Patients

    Seq Age Sex Outcome Treatment
    1