BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPNC LASER SHEATH/LEAD LOCKING DEVICE

    MDR report key: 1661793 · Received April 16, 2010

    Report

    Report Number
    1721279-2010-00014
    Event Type
    Death
    Date Received
    April 16, 2010
    Date of Event
    March 25, 2010
    Report Date
    April 16, 2010
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MFR DATES FOR ALL DEVICES: UNK.

    Description of Event or Problem · 1

    INDICATION FOR PROCEDURE: ACUTE INFECTION, STATUS-POST DEVICE UPGRADE. PROCEDURE: ICD LEAD REMOVAL OF A SINGLE RV LEAD; IMPLANTATION DATE WAS 2004. MD ATTACHED A LLD-EZ DEVICE TO THE DISTAL END OF THE LEAD, THEN BEGAN LASING WITH A 16F SLS. DURING THE EXTRACTION OF THE CARDIAC LEAD, THE PT'S BLOOD PRESSURE BEGAN DROPPING, MEDICATION WAS GIVEN, PT'S PRESSURE STABILIZED. MD AGAIN BEGAN EXTRACTING, THE PT'S PRESSURE AGAIN DROPPED, AN EMERGENT THORACOTOMY WAS PERFORMED, BUT RESUSCITATION WAS UNSUCCESSFUL. ANALYSIS: THERE WERE NO DEVICES RETURNED FOR ANALYSIS. NO PRODUCT-RELATED COMPLAINTS ASSOCIATED WITH THIS EVENT REPORTED BY THE PHYSICIAN. PT OUTCOME: SVC PERFORATION RESULTING IN PT DEATH.

    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 / 518-062 UNK / UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death GENERATION 4 EXCIMER LASER