BEUDAMED
    FDA Adverse Event Summary report: N

    SLS II

    MDR report key: 1914808 · Received October 12, 2010

    Report

    Report Number
    1914808
    Date Received
    October 12, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 8, 2010
    Manufacturer
    SPECTRANETICS
    Product Code
    MFA
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE DECISION WAS MADE TO EXTRACT THE ST. JUDE RIATA ICD LEAD DUE TO INAPPROPRIATE NOISE SENSED ON THE LEAD. WHILE REMOVING THE LEAD USING THE SPECTRANETICS LASER LEAD REMOVAL SYSTEM, A TEAR AT THE RIGHT ATRIAL SUPERIOR VENA CAVA (SVC) JUNCTION WAS MADE. THE LEAD ITSELF DID NOT CONTRIBUTE TO THE DEATH OF THE PATIENT. THE DEATH OCCURRED AS A COMPLICATION THAT CAME WITH THE LEAD EXTRACTION PROCEDURE.====================== HEALTH PROFESSIONAL'S IMPRESSION======================THE PHYSICIAN DID NOT BELIEVE THE LASER LEAD EXTRACTOR WAS FAULTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SLS II REMOVAL SYSTEM, LEAD, LASER SHEATH MFA SPECTRANETICS 500-012 C10B25B
    2 RIATA LEAD, DEFIBRILLATION LWS ST. JUDE MEDICAL 1590/60 *
    3 CVX-300 EXCIMER LASER SYSTEM MFA SPECTRANETICS CVX-300 *

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR