BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPNC LASER SHEATH

    MDR report key: 1679020 · Received May 10, 2010

    Report

    Report Number
    1721279-2010-00018
    Event Type
    Death
    Date Received
    May 10, 2010
    Date of Event
    April 19, 2010
    Report Date
    May 10, 2010
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER DATES FOR ALL DEVICES: UNKNOWN.

    Description of Event or Problem · 1

    INDICATION FOR PROCEDURE: BATTERY CHANGE WITH REMOVAL OF RECALLED MDT SPRINT FIDELIS LEAD (RV). PROCEDURE: THIS WAS A LEFT-SIDED PROCEDURE CONDUCTED IN THE EP LAB. THE MD ATTACHED THE LLD-EZ TO THE DISTAL TIP OF THE CARDIAC LEAD AND BEGAN LASING WITH A 14F SLS. THE MD LASED FOR APPROX 16+ MINUTES WITH MINIMAL PROGRESS NOTED. THE MD THEN UP SIZED TO A 16F SLS, PASSING WITH RELATIVE EASE TO THE PROXIMAL COIL AND LASED FOR APPROX 4 MINUTES. AT THIS TIME, IT WAS NOTED THE PT'S RESPIRATORY RATE HAD CHANGED. THE ANESTHESIOLOGIST WAS CALLED, CAME INTO THE ROOM WITHIN MINUTE AND BEGAN BAGGING THE PT. THE MD PERFORMED A PERICARDIOCENTESIS, CPR INITIATED AND A CODE WAS CALLED. CPR CONTINUED FOR APPROX 40 MINUTES UNTIL THE MD CALLED A HALT TO THE RESUSCITATION EFFORTS. ANALYSIS: THERE WERE NO DEVICES RETURNED FOR ANALYSIS. NO PRODUCT-RELATED COMPLAINTS ASSOCIATED WITH THIS EVENT WERE REPORTED BY THE PHYSICIAN. PATIENT OUTCOME: DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPNC LASER SHEATH 16F SLS MFA SPECTRANETICS CORP. 500-013 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death 14F SLS (UNK LOT#)| GENERATION 4 EXCIMER LASER