BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE Z

    MDR report key: 3861593 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07229
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P850089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE MEDIAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND THE PROXIMAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE AT THE FIRST RIB/CLAVICLE LOCATION WHILE IN VIVO. IT WAS NOTED THE PROXIMAL CONDUCTOR OF THE LEAD BECAME DISTORTED AT THE FIRST RIB/CLAVICLE LOCATION WHILE IN VIVO, THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH AT THE FIRST RIB/CLAVICLE LOCATION WHILE IN VIVO AND THE OUTER INSULATION OF THE LEAD WAS OBSERVED TO HAVE BLOOD INGRESSION. CONCOMITANT MEDICAL PRODUCTS: ADDR01 IPG, IMPLANTED: (B)(6) 2013. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DEVELOPED AN INFECTION. THE LEADS WERE REMOVED. THE LEADS WERE RETURNED TO THE MANUFACTURER AND TESTED OUT OF SPECIFICATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342863 CAPSURE Z ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5034

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Hospitalization| R 5534-45 LEAD