BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPNC LASER SHEATH/LEAD LOCKING DEVICE

    MDR report key: 1700770 · Received May 26, 2010

    Report

    Report Number
    1721279-2010-00024
    Event Type
    Injury
    Date Received
    May 26, 2010
    Date of Event
    January 1, 2009
    Report Date
    May 25, 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

    THIS IS TO REPORT AN ADVERSE EVENT DURING A LEAD REMOVAL CASE AT THE UNIVERSITY OF MIAMI HOSPITAL, DATE OF PROCEDURE IS UNK AT THIS TIME. THE PT'S INJURY WAS A SVC PERFORATION, UNK THE PT'S POST-OPERATIVE STATUS. KNOWLEDGE OF THE ADVERSE EVENT WAS DURING A LITERATURE REVIEW CONDUCTED ON 5/7/10. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFO WITHOUT SUCCESS.

    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 UNK/UNK

    Patients

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