BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPNC LASER SHEATH/LEAD LOCKING DEVICE

    MDR report key: 1627994 · Received March 9, 2010

    Report

    Report Number
    1721279-2010-00006
    Event Type
    Injury
    Date Received
    March 9, 2010
    Date of Event
    February 10, 2010
    Report Date
    March 9, 2010
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER DATES FOR ALL DEVICES: UNKNOWN.

    Description of Event or Problem · 1

    INDICATION FOR PROCEDURE: ACUTE INFECTION. PROCEDURE: THIS WAS A LEFT SIDED PROCEDURE TO EXTRACT AN ICD LEAD (RV). THE CASE WAS PERFORMED IN THE CARDIAC CATHETER LAB, WITH AN ARTERIAL LINE AND FLUOROSCOPY USED THROUGHOUT THE CASE. MD USED BOTH A SLS AND LLD (UNKNOWN SIZES) TO REMOVE THE LEAD. AFTER THE LEAD WAS REMOVED THE PATIENT'S BLOOD PRESSURE DECREASED. THE CT SURGEON OPENED THE PATIENT'S CHEST TO REPAIR AN AORTA TEAR. THE REPAIR WAS SUCCESSFUL. ANALYSIS: THE DEVICES WERE DISPOSED OF DURING THE CODE AND WERE NOT RETURNED FOR ANALYSIS. THERE WERE NO ALLEGED DEFECTS OR NON-CONFORMANCES OF THE SPNC DEVICES. PATIENT OUTCOME: PATIENT RECOVERED AND WAS DISCHARGED WITH NO REPORTED DEFICITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPNC LASER SHEATH/LEAD LOCKING DEVICE SLS / LLD MFA SPECTRANETICS CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention GENERATION 4 EXCIMER LASER