BEUDAMED
    FDA Adverse Event Death Summary report: N

    LEAD LOCKING DEVICE

    MDR report key: 2805319 · Received October 25, 2012

    Report

    Report Number
    1721279-2012-00147
    Event Type
    Death
    Date Received
    October 25, 2012
    Date of Event
    October 3, 2012
    Report Date
    October 3, 2012
    Manufacturer
    SPECTRANETICS CORPORATION
    Product Code
    DRB
    PMA / PMN Number
    K043401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN IN THIS CASE COMMUNICATED TO THE (B)(4) SALES REPRESENTATIVE ON (B)(4) 2012, THAT THE PATIENT HAD UNFORTUNATELY SUFFERED A CVA AND DIED ON (B)(6) 2012.

    Description of Event or Problem · 1

    THIS WAS A LEFT SIDED CARDIAC LEAD EXTRACTION CONDUCTED IN THE EP LAB TO REMOVE A TOTAL OF 2 LEADS (RV-SJM 1580 RIATA, 96MTHS; RA - SJM 1688 SDX TENDRIL, 18MTHS) DUE TO A FRACTURED, NON-FUNCTIONING ICD LEAD. THE PATIENT WAS ASKED TO COME IN FOR A LEAD EXCHANGE AFTER SUFFERING INAPPROPRIATE SHOCKS. THE PATIENT WAS PREPPED PER HRS RECOMMENDED STANDARDS; BASELINE ARTERIAL BLOOD PRESSURE (ABP) WAS 140/82. THE MD OPENED THE POCKET, CUT AND INSERTED A LLD-EZ INTO THE RV LEAD. THE MD SUCCESSFULLY RETRACTED THE RV LEAD'S COIL BUT THE LEAD WOULD NOT RELEASE. IT WAS NOTED ON FLUOROSCOPY APPROXIMATELY 2 CM OF EXPOSED CABLES BETWEEN THE PROXIMAL AND DISTAL COILS OF THE LEAD. LASING BEGAN WITH THE 16F GLIDELIGHT WITHOUT AN OUTER SHEATH; THE PATIENT'S ABP WAS APPROX 120. PROGRESSION WAS MADE OVER 2/3 OF THE PROXIMAL COIL, LASER SHEATH WAS NOT YET TO THE SVC WHEN THE LEAD RELEASED FROM THE WALL; PATIENT'S ABP WAS APPROX 110. THE MD STOPPED LASING AND WATCHED THE MONITOR AND THE ABP CONTINUED TO DROP TO APPROX 60. AT 1441, BLOOD WAS CALLED FOR AND THE CVS/OR TEAM CALLED TO PREP FOR AN EMERGENT STERNOTOMY. AT 1443, CPR WAS STARTED, AT 1444, THE PATIENT WAS INTUBATED AND AT 1445, THE CVS WAS IN THE ROOM. TEE CONFIRMED A RIGHT PLEURAL SPACE EFFUSION. AT 1447, THE PATIENT WAS TRANSPORTED NEXT DOOR TO THE OR AND AT 1450, THE CVS PERFORMED A STERNOTOMY. A PERFORATION IN THE RV WAS FOUND AND SUCCESSFULLY REPAIRED. THE RA LEAD WAS SUCCESSFULLY EXTRACTED DURING THE OPEN CHEST REPAIR. THE PATIENT WAS TRANSPORTED TO THE ICU AND MADE A SUCCESS RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD LOCKING DEVICE LLD-EZ DRB SPECTRANETICS CORPORATION 518-062 FLP12H16A

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Death| H| L| R CVX-300 EXCIMER LASER SYSTEM| SJM 1580 RIATA DUAL COIL ICD LEAD| SJM 1688 SDX TENDRIL| 16F GLIDELIGHT LASER SHEATH