BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN OTW

    MDR report key: 3181920 · Received June 21, 2013

    Report

    Report Number
    2649622-2013-08117
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 23, 2013
    Manufacturer
    MPRI
    Product Code
    LWP
    PMA / PMN Number
    P010015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: (B)(4) - THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO ESC (ENVIRONMENTAL STRESS CRACKING) WHILE IN VIVO, VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE, VISUAL SUMMARY ANALYSIS OF THE LEAD WAS PERFORMED ONLY. CONCOMITANT PRODUCTS: PRODUCT ID D314TRM, IMPLANTED: (B)(6) 2013; PRODUCT ID 6947M55, IMPLANTED: (B)(6) 2013; PRODUCT ID 5076-45, IMPLANTED: (B)(6) 2004. (B)(4).

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND TESTED OUT OF SPECIFICATION. REPORTED INFORMATION INDICATED THE DEVICE WAS EXPLANTED POST-MORTEM AND THE CAUSE OF DEATH WAS NOT RELATED TO THE OUT OF SPECIFICATION FINDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283397 ATTAIN OTW PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MPRI 419478

    Patients

    Seq Age Sex Outcome Treatment
    1