BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LASER SHEATH II

    MDR report key: 2103695 · Received May 20, 2011

    Report

    Report Number
    1721279-2011-00034
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    March 16, 2011
    Report Date
    April 20, 2011
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    PMA / PMN Number
    P960042
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A LEAD REMOVAL PROCEDURE OF WHICH VERY LITTLE IS KNOWN AT THIS TIME. THE CASE WAS PERFORMED ON (B)(6) 2011 USING A 12F SLS AND APPROX 3-4 DAYS POST-OPERATIVELY THE PT PRESENTED WITH FEVER. A CHEST CT CONFIRMED THE PT HAD EMBOLIC PNEUMONIA. THE PT UNDERWENT SURGERY AND RECOVERED SUCCESSFULLY. AN INITIAL REPORT HAS ALSO BEEN FILED WITH THE PMDA AND THE INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRANETICS LASER SHEATH II 12F SLS II MFA SPECTRANETICS CORP. 500-001 C10L03B

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| L| R CVX-300 EXCIMER LASER SYSTEM: SERIAL# (B)(4)