BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPNC LASER SHEATH & LEAD LOCKING

    MDR report key: 1732855 · Received June 17, 2010

    Report

    Report Number
    1721279-2010-00029
    Event Type
    Death
    Date Received
    June 17, 2010
    Date of Event
    May 19, 2010
    Report Date
    June 17, 2010
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER DATES FOR ALL DEVICES: UNK.

    Description of Event or Problem · 1

    INDICATION FOR PROCEDURE: ACUTE INFECTION. PROCEDURE: THIS WAS LEFT SIDED PROCEDURE CONDUCTED IN OPERATING ROOM TO REMOVE 2 OUT OF 3 TOTAL CARDIAC LEADS (EPICARDIAL LEAD WAS FUNCTIONING AND WAS NOT REMOVED). THE LEADS WERE PREPPED WITH LLD-EZ, THEN MD BEGAN LASING WITH A 16F SLS. BOTH LEADS WERE REMOVED SUCCESSFULLY. IMMEDIATELY PROCEEDING THE EXPLANT OF THE DEFIBRILLATOR LEAD THE PT'S ARTERIAL PRESSURE DROPPED, THE CV SURGEON PERFORMED A TRANSESOPHAGEAL ECHOCARDIOGRAM AND CONFIRMED A 2-3CM SVC TEAR. THE PT'S CHEST WAS EMERGENTLY OPENED AND THE SVC TEAR WAS REPAIRED SUCCESSFULLY. THE PT REMAINED INTUBATED AND TRANSFERRED TO THE ICU. DEVICE ANALYSIS: ALL DEVICES WERE DISPOSED OF DURING EMERGENT THORACOTOMY. THE DEVICE'S SERIAL CODES WERE UNK, THUS PREVENTING A PRODUCT LOT HISTORY REVIEW. THE MD DOES NOT BELIEVE THE SPNC DEVICES CAUSED THE PT'S INJURY. PT STATUS: PT EXPIRED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPNC LASER SHEATH & LEAD LOCKING 16F SLS AND LLD-EZ MFA SPECTRANETICS CORP. 500-013 / 518-062 UNK/UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death GENERATION 4 EXCIMER LASER