BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEAD LOCKING DEVICE #1

    MDR report key: 2708697 · Received April 11, 2012

    Report

    Report Number
    1721279-2012-00032
    Event Type
    Injury
    Date Received
    April 11, 2012
    Date of Event
    March 13, 2012
    Report Date
    March 13, 2012
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    DRB
    PMA / PMN Number
    K043401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS WAS A LEFT-SIDED, MANUAL CARDIAC LEAD EXTRACTION OF ONE, RV LEAD (UNKNOWN MODEL#; (B)(6)) DUE TO AN ACUTE INFECTION. THE MD CUT AND PREPPED THE RV LEAD WITH A LLD #1, UTILIZING THE VISISHEATH (UNKNOWN SIZE) TO MANUALLY DISSECT THE TISSUE AWAY FROM THE LEAD. THE MD ENCOUNTERED INCREASED ADHESIONS PRIOR TO ENTERING THE SVC, INCREASING TRACTION ON THE LLD #1 THE DEVICE EVENTUALLY BROKE INSIDE THE RV LEAD. THE MD DECIDED TO CAP THE LLD/LEAD AND CONTACT THE (B)(6) FOR AN OPEN CHEST EXTRACTION. THERE WAS NO EVIDENCE OF INJURY AND THE PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. APPROXIMATELY 2 HOURS LATER THE PATIENT WAS PLACED UNDER GENERAL ANESTHESIA, A STERNOTOMY WAS PERFORMED AND THE RV LEAD/LLD WAS SUCCESSFULLY EXTRACTED. THE PATIENT WAS TRANSFERRED TO THE ICU FOR RECOVERY. NO SPNC DEVICES WERE RETAINED FOR RETURN ANALYSIS AND REQUESTS FOR LOT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD LOCKING DEVICE #1 LLD #1 DRB SPECTRANETICS CORP. 518-18 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention VISISHEATH DILATOR SHEATH (UNKNOWN SIZE)| RV LEAD (UNKNOWN MODEL #)