BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LLD #2

    MDR report key: 1152353 · Received September 8, 2008

    Report

    Report Number
    1152353
    Event Type
    Malfunction
    Date Received
    September 8, 2008
    Date of Event
    August 8, 2008
    Report Date
    September 8, 2008
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    MFA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE CARDIOLOGIST WAS ATTEMPTING TO EXPLANT PACEMAKER GENERATOR AND PACING LEADS. USING THE LASER REMOVAL SYSTEM, HE ATTEMPTED TO SNARE THE RIGHT ATRIAL LEAD, BUT ENCOUNTERED SIGNIFICANT CALCIFICATION OF THE LEAD TRACT. THE DECISION WAS MADE TO ABANDON THE RIGHT ATRIAL LEAD, SO THE DOCTOR ATTEMPTED TO REMOVE THE LASER SYSTEM. THE DEVICE WOULD NOT UNLOCK DESPITE MULTIPLE ATTEMPTS. SINCE THE LEAD COULD NOT BE REMOVED AND THE LOCKING STYLET WOULD NOT UNLOCK FROM THE LEAD, THE END OF THE STYLET HAD TO BE CUT OFF AND LEFT INSIDE THE PATIENT, ATTACHED TO THE RIGHT ATRIAL LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LLD #2 LASER, CARDIAC LEAD REMOVAL SYSTEM MFA SPECTRANETICS CORPORATION * 070522

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR