BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1853688 · Received October 5, 2010

    Report

    Report Number
    2124215-2010-15150
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    July 21, 2010
    Report Date
    August 31, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS NOT IMPLANTED. ANOTHER BOSTON SCIENTIFIC CRM RV DEFIBRILLATION LEAD WAS SUCCESSFULLY IMPLANTED. THE INTACT PORTION OF THE LEAD WAS REMOVED AND HAS BEEN RETURNED. ANALYSIS OF THE RETURNED PRODUCT IS CURRENTLY IN PROGRESS. NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ANY ADDITIONAL INFORMATION RELATED TO THIS EVENT BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE PHYSICIAN DID NOT BELIEVE THERE WOULD BE ANY LONG TERM COMPLICATIONS RESULTING FROM THE LEAD FRAGMENT RESIDING IN THE PATIENT.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT BOSTON SCIENTIFIC, CRM'S POST MARKET QUALITY ASSURANCE LABORATORY, THE LEAD WAS THOROUGHLY INSPECTED AND ANALYZED. VISUAL INSPECTION REVEALED THE LEAD WAS RETURNED INSIDE THE SAFE SHEATH INTRODUCER, WITH THE DISTAL TIP PORTION MISSING. THE SAFE SHEATH WAS LOCATED OVER THE LEAD BODY BETWEEN THE PROXIMAL AND DISTAL SHOCKING COILS. THE LEAD BODY PROXIMAL OF THE SAFE SHEATH IS EXTREMELY TWISTED AND CURLED INTO A PIGTAIL. THE LEAD BODY DISTAL OF THE SAFE SHEATH IS EXTREMELY STRETCHED WITH THE RATE/SENSE COILS STRAIGHTENED AND THE ENDS ARE FRACTURED. THE SAFE SHEATH INTRODUCER WAS THEN CRACKED OPEN. THE INNER WALL OF THE SAFE SHEATH AND LEAD INSULATION BOTH APPEARED NORMAL AND WITHOUT BUNCHING, BUT DRIED BODY FLUID/BLOOD WAS NOTED. NO TESTS WERE PERFORMED DUE TO THE CONDITION OF THE RETURNED LEAD. ANALYSIS CONFIRMED THAT THE DISTAL TIP HAD BROKEN OFF AS THIS PORTION OF THE LEAD WAS NOT RETURNED. CLOSE INSPECTION INDICATED THE COILS SUFFERED FROM A DUCTILE FRACTURE, MOST LIKELY DUE TO EXCESSIVE STRETCHING. EXCESSIVE DAMAGE LIKELY INDUCED HANDLING DAMAGE.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD WAS REPOSITIONED MULTIPLE TIMES DURING THE IMPLANT PROCEDURE. THE PATIENT HAS AN ENLARGED HEART AND ACCEPTABLE LEAD PLACEMENT WAS NOT OBTAINED. THE TIP OF THE LEAD AND DISTAL COIL INADVERTENTLY BROKE OFF WHILE THE PHYSICIAN WAS TRYING TO REMOVE THE LEAD AND REMAIN IN THE SUPERIOR VENA CAVA. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening