BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPNC LASER SHEATH/LEAD LOCKING DEVICE

    MDR report key: 1672713 · Received April 30, 2010

    Report

    Report Number
    1721279-2010-00016
    Event Type
    Death
    Date Received
    April 30, 2010
    Date of Event
    April 2, 2010
    Report Date
    April 30, 2010
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURE DATES FOR ALL DEVICES ARE UNK.

    Description of Event or Problem · 1

    INDICATION FOR PROCEDURE: ICD LEAD CHRONIC ENDOCARDITIS. PROCEDURE: THIS WAS A LEFT-SIDED LEAD REMOVAL CASE WITH INTENT TO REMOVE 1 RA LEAD AND 2 RV ICD LEADS. MD ATTACHED THE LLD-EZ TO THE DISTAL TIP OF THE RA LEAD AND BEGAN LASING WITH A 16F SLS. UPON SUCCESSFUL REMOVAL OF THE RA LEAD, IT WAS NOTED THE PT'S BLOOD GLUCOSE PRESSURE BEGAN DROPPING SIGNIFICANTLY. IT WAS DETERMINED THAT THE 2 RV LEADS WOULD BE ABANDONED, AN EMERGENT THORACOTOMY WAS PERFORMED IN THE OPERATING ROOM. THE RESUSCITATION EFFORT WAS UNSUCCESSFUL. ANALYSIS: THERE WERE NO DEVICES RETURNED FOR ANALYSIS. NO PRODUCT-RELATED COMPLAINTS ASSOCIATED WITH THIS EVENT WERE REPORTED BY THE PHYSICIAN. CAUSE OF DEATH: "HEMORRHAGIC SHOCK" (PER FACILITY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPNC LASER SHEATH/LEAD LOCKING DEVICE 16F SLS / LLD-EZ MFA SPECTRANETICS CORP. 500-013 / 518-019 UNK / UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death GENERATION 4 EXCIMER LASER