BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRANETICS LLZ EZ LEAD LOCKING DEVICE

    MDR report key: 6585940 · Received May 23, 2017

    Report

    Report Number
    1721279-2017-00098
    Event Type
    Injury
    Date Received
    May 23, 2017
    Date of Event
    May 2, 2017
    Report Date
    May 2, 2017
    Manufacturer
    SPECTRANETICS
    Product Code
    DRB
    PMA / PMN Number
    K142116
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 510K NUMBER HAS BEEN CORRECTED TO REFLECT THE MOST CURRENT AND UP TO DATE NUMBER, AS OF THE DATE OF THE INITIAL REPORT.

    Additional Manufacturer Narrative · 1

    PATIENT'S MEDICAL HISTORY/CO-MORBIDITIES UNAVAILABLE FROM FACILITY PHYSICIAN'S FIRST NAME UNAVAILABLE FROM FACILITY.

    Description of Event or Problem · 1

    PROCEDURE TO REMOVE NON FUNCTIONAL RV LEAD. HEAVY SCAR TISSUE WAS PRESENT AT THE TIP OF THE LEAD. LLD AND GLIDELIGHT DEVICES IN USE. ONCE THE RV LEAD RELEASED FROM THE RV APEX, THE PATIENT'S BP DROPPED. AN RV APEX INJURY WAS DISCOVERED AND RESCUE EFFORTS COMMENCED IMMEDIATELY. THE INJURY WAS REPAIRED AND THE PATIENT SURVIVED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366489 SPECTRANETICS LLZ EZ LEAD LOCKING DEVICE LLD DRB SPECTRANETICS 518-062 FLP17A13A

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| L| R SPECTRANETICS 14F GLIDELIGHT LASER SHEATH| SPECTRANETICS CVX-300 EXCIMER LASER