BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECTSECURE

    MDR report key: 3992872 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09625
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE A SIMILAR MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT MEDICAL PRODUCTS: D234TRK ICD 419688 LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SUSPECTED INFECTION. CHEST X-RAY SHOWED SHADOWS AROUND THE ATRIAL LEAD AND THE PHYSICIAN DECIDED TO EXPLANT THE ENTIRE SYSTEM. VISUAL INSPECTION AFTER EXTRACTING THE ATRIAL LEAD WHERE NORMAL ¿ NO FIBROTIC MATERIAL WAS SEEN ON THE LEAD. MEASUREMENTS WERE ALL NORMAL BEFORE EXTRACTING. INSULATION DAMAGE WAS ALSO NOTED UNDER THE SLEEVE OF THE LEFT VENTRICULAR LEAD. THE IMPLANTABLE CARDIAC DEFIBRILLATOR (ICD) AND ALL LEADS WERE EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471291 SELECTSECURE DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 383059

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Hospitalization| R 6944-65 LEAD