BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPNC LASER SHEATH/LEAD LOCKING DEVICE

    MDR report key: 1692869 · Received May 17, 2010

    Report

    Report Number
    1721279-2010-00019
    Event Type
    Injury
    Date Received
    May 17, 2010
    Date of Event
    April 15, 2010
    Report Date
    May 17, 2010
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER DATES FOR ALL DEVICES: UNKNOWN.

    Description of Event or Problem · 1

    INDICATION FOR PROCEDURE: ATRIAL LEAD FRACTURE AND REMOVAL OF REDUNDANT LEADS AS A MEANS OF OPENING A CHANNEL IN AN OCCLUDED VESSEL FOR RE-IMPLANTATION. PROCEDURE: THIS WAS A LEFT-SIDED PROCEDURE THAT TOOK PLACE IN THE OPERATING ROOM TO REMOVE 3 CARDIAC LEADS (2/RV AND 1/RA). THE INITIAL PLACEMENT WAS APPROXIMATELY 14 YRS AGO (1/RA AND I/RV), WITH THE LAST RV PLACEMENT 4 YRS AGO. THE MD ATTACHED A LLD-EZ TO THE DISTAL TIP OF EACH LEAD AND LASED WITH A 14F SLS. DURING THE REMOVAL OF THE ICD LEAD, THE PT'S BLOOD PRESSURE BEGAN DROPPING AND DID NOT RECOVER. THE PT'S CHEST WAS OPENED IN UNDER 2 MINUTES. TWO PERFORATIONS OF THE SVC AT THE RIGHT ATRIAL JUNCTION WERE REPAIRED SUCCESSFULLY. ANALYSIS: THERE WERE NO DEVICES RETURNED FOR ANALYSIS. NO PRODUCT-RELATED COMPLAINTS ASSOCIATED WITH THIS EVENT WERE REPORTED BY THE PHYSICIAN. PATIENT OUTCOME: THE PT WAS REPORTED AS BEING "STABLE" FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPNC LASER SHEATH/LEAD LOCKING DEVICE 14F SLS / LLD-EZ MFA SPECTRANETICS CORP. 500-012 / 518-062 UNK / UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention GENERATION 4 EXCIMER LASER