BEUDAMED
    FDA Adverse Event Death Summary report: N

    TARGET TIP

    MDR report key: 3242526 · Received July 23, 2013

    Report

    Report Number
    2649622-2013-08244
    Event Type
    Death
    Date Received
    July 23, 2013
    Report Date
    June 24, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K822781
    Adverse Event
    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. THE MANUFACTURE DATE WAS UNABLE TO BE OBTAINED, IF INFORMATION IS PROVIDED AT A LATER DATE 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, THERE WAS BLOOD ON THE DISTAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED, THE OUTER INSULATION OF THE LEAD DEVELOPED COSMETIC ESC (ENVIRONMENTAL STRESS CRACKING) WHILE IN VIVO, VISUAL SUMMARY ANALYSIS OF THE LEAD WAS PERFORMED ONLY. PRODUCT ID: 6957J, IMPLANTED: (B)(6) 1996. (B)(4).

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER POST MORTEM WITH NO CAUSE OF DEATH REPORTED. THE DEVICE WAS ANALYZED AND TESTED OUT OF SPECIFICATION. FOLLOW UP WAS ATTEMPTED TO OBTAIN A CAUSE OF DEATH AND WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344272 TARGET TIP ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 401158

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R