BEUDAMED
    FDA Adverse Event Summary report: N

    ST. JUDE MEDICAL

    MDR report key: 2579739 · Received May 14, 2012

    Report

    Report Number
    MW5025404
    Date Received
    May 14, 2012
    Date of Event
    March 21, 2012
    Report Date
    May 14, 2012
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THERE APPEARS TO BE AN ABRASION WITH EXTERNALIZATION OF THE CONDUCTOR WIRES AT THE ELBOW PROXIMAL TO THE RIGHT VENTRICULAR COIL OF THE ST JUDE MEDICAL 7000 RIATA ST FOUND ON FLUOROSCOPY (B)(6) 2012. ON (B)(6) 2012, UNDERWENT LEAD EXTRACTION WITH THE FOLLOWING COMPLICATION: THERE WAS AN SVC TEAR AND THE CHEST HAD TO BE OPENED URGENTLY. SHE WENT ON PUMP AND A PERICARDIAL PATCH PLACED. THE TIP COULD NOT BE EXTRACTED. ALONG WITH THE SIGNIFICANT BREACH IN THE ELBOW, THERE WAS AN INSIDE OUT ABRASION BELOW THE YOKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE MEDICAL RIATA 7000 LWS ST. JUDE MEDICAL 7000

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other