BEUDAMED
    FDA Adverse Event Other Summary report: N

    LLD #1 / LLD E

    MDR report key: 1174585 · Received September 22, 2008

    Report

    Report Number
    1721279-2008-00023
    Event Type
    Other
    Date Received
    September 22, 2008
    Date of Event
    July 31, 2008
    Report Date
    August 5, 2008
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    DRB
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS: THE LLDS HAVE BEEN RETAINED BY THE HOSPITAL'S RISK MANAGEMENT DEPARTMENT AND WILL NOT RETURN THEM TO (B)(4) PER THE REP. THE MD WAS REPORTEDLY USING A LOT OF FORCE WITH THE LLD DEVICES AND IS RELATIVELY NEW AT CARDIAC LEAD REMOVAL PROCEDURES. MD REPORTED "I DON'T THINK IT HAD ANYTHING TO DO WITH THE (B)(4) DEVICES" TO THE REP THAT WAS PRESENT DURING THIS CASE.

    Description of Event or Problem · 1

    CLINICAL HISTORY: ADMITTED FOR INFECTED LEAD. PROCEDURE: THE PHYSICIAN WAS ATTEMPTING A LEAD REMOVAL CASE. THE MD BROKE THREE LLD-1 DEVICES IN A ROW, THEN UTILIZED A COOK MANUAL WHICH DID NOT WORK AND THEN ATTEMPTED TO USE A LLD-E THAT DID NOT BREAK. THE PHYSICIAN EVENTUALLY HAD TO CUT & CAP THE DEVICE/LEAD AND LEAVE IT IN THE PT. SO THE END OF THE LLD WAS LEFT INSIDE THE CARDIAC LEAD. PATIENT OUTCOME: THE PT WAS REPORTEDLY OKAY PROCEEDING THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LLD #1 / LLD E LEAD LOCKING DEVICE DRB SPECTRANETICS CORP. 518-018

    Patients

    Seq Age Sex Outcome Treatment
    1 Other SPECTRANETICS CVX-300 LASER