BEUDAMED
    FDA Adverse Event Other Summary report: N

    LEAD LOCKING DEVICE# 2/LEAD LOCKING DEVICE EZ

    MDR report key: 1198944 · Received September 26, 2008

    Report

    Report Number
    1721279-2008-00027
    Event Type
    Other
    Date Received
    September 26, 2008
    Date of Event
    August 29, 2008
    Report Date
    September 23, 2008
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    DRB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT OUTCOME: THE PATIENT WAS STABILIZED FOLLOWING A SURGICAL REMOVAL OF THE RV LEAD IN THE OPERATING ROOM, PLACED ON ANTIBIOTICS FOR 7 DAYS AND REIMPLANTED WITH A NEW, COMPLETE PACING SYSTEM THE FOLLOWING FRIDAY. PT IS RECOVERING WELL AT THE TIME OF THIS REPORT. INVESTIGATION SUMMARY: THERE WERE NO DEVICES RETURNED FOR FAILURE ANALYSIS. HOWEVER, THERE IS NO INDICATION THAT THE EVENT WAS CAUSED BY A MALFUNCTION OF THE SPECTRANETICS DEVICES. ADDITIONAL DEVICES UTILIZED: 14F SLS / 16F SLS. LOT# 500-012 / 500-013. SERIAL#: UNK.

    Description of Event or Problem · 1

    CLINICAL HISTORY: PT WAS A (B) (6), FEMALE COMING IN FOR A PACEMAKER BATTERY CHANGE, BOTH EXISTING ATRIAL LEAD REMOVAL AND A NEW ATRIAL AND RV LEAD PLACED. THE RV (ENDOTAK) AND ONE ATRIAL LEAD WERE 22 YRS OLD. THE 3RD LEAD (MEDTRONIC ATRIAL LEAD) WAS POORLY PLACED AND 2YRS OLD. PROCEDURE: THE NEWEST ATRIAL LEAD WAS REMOVED WITH GENTLE TRACTION, WITHOUT THE SLS OR LLD, SLIDING RIGHT OUT. THE OLDEST ATRIAL LEAD WAS LOADED WITH A LLD-EZ AND 14F SLS PLACED OVER THE LEAD. IT WAS AT THIS POINT THE MD NOTED THE TWO REMAINING LEADS WERE FUSED TOGETHER BY SCAR TISSUE. LASING OVER THE ATRIAL LEAD WITH A 16F SLS, RESULTING IN LEAD REMOVAL. A DECISION WAS MADE AT THIS POINT TO GO BACK AND RETRIEVE THE RV LEAD. LASING AGAIN INTERMITTENTLY WITH THE 16F SLS OVER THE RV LEAD TAKING THE SHEATH AND OUTER SHEATH AROUND THE CURVE OF THE SVC. IT WAS AT THIS POINT THAT THE PT'S PRESSURE DROPPED FROM 90 TO 20. THE SHEATH WAS REMOVED AND A CODE CALLED. THE SURGEON AND OPERATING ROOM TEAM ARRIVED, PERFORMED A THORACOTOMY, CONTROLLED THE SVC BLEED, AND SUCCESSFULLY REPAIRED THE PERFORATION IN THE OPERATING ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD LOCKING DEVICE# 2/LEAD LOCKING DEVICE EZ LLD#2/LLD EZ DRB SPECTRANETICS CORP. 518-019/518-062 UNK/UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention SPECTRANETICS CVX-300 LASER