BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2053017 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04313
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 4, 2011
    Report Date
    April 8, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE AND LEAD WERE LATER EXPLANTED. A RETURN REQUEST WAS MADE FOR THESE PRODUCTS.

    Additional Manufacturer Narrative · 1

    UPON RETURN TO OUR QUALITY ASSURANCE LABORATORY, THE LEAD UNDERWENT DETAILED ANALYSIS. VISUAL OBSERVATIONS NOTED SETSCREW MARKS WERE NOTED ON THE IS-1 TERMINAL PIN, AND ON THE DISTAL AND PROXIMAL HIGH VOLTAGE TERMINAL PINS. THERE WERE NO DISCERNABLE SETSCREW MARKS ON THE IS-1 RING. THE PROXIMAL CABLE TO COIL CRIMP HAS BEEN PULLED IN THE DIRECTION OF THE TERMINAL PINS. THE COIL WAS STRETCHED AND THE INSULATION WAS TORN AS WELL. THE MEDICAL ADHESIVE WAS TORN/SEPARATED FROM THE GORE AT THE PROXIMAL END OF THE PROXIMAL SPRING ELECTRODE. THE DISTAL END OF THE PROXIMAL SPRING ELECTRODE WAS SEPARATED FROM THE LEAD BODY INSULATION AND MEDICAL ADHESIVE WAS NOTED. THE PROXIMAL END OF THE DISTAL SPRING ELECTRODE WAS SEPARATED FROM THE LEAD BODY INSULATION AND MEDICAL ADHESIVE WAS ALSO NOTED. THE LEAD BODY WAS SLIGHTLY CURLED AND IT APPEARED THAT THE LEAD WAS PULLED WITH FORCE AND THEN LET GO. BLOOD/BODY FLUID WAS NOTED IN THE HELIX HOUSING. THE HELIX MECHANISM TEST FAILED MOST LIKELY DUE TO BODY FLUID INFILTRATION. HOWEVER, THE LEAD PASSED ELECTRICAL INTEGRITY TESTING. THE ALLEGATION COULD NOT BE CONFIRMED BY ANALYSIS.

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE PRODUCTS REMAIN IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND VENTRICULAR LEAD MEASURED HIGH THRESHOLDS AND A LOSS OF CAPTURE. THE PATIENT HAD BEEN ON PACING IN THE LEFT VENTRICLE. THERE WAS INQUIRY OF THE HEADER OF THE DEVICE. THE PHYSICIAN HAD SCHEDULED THE PATIENT FOR A REVISION. THERE WAS MENTION THAT THE DEVICE MAY ALSO ELECTIVELY BE REPLACED FOR A DEVICE WITH A STRONGER HEADER BOND. NO ALLEGATIONS WERE REPORTED REGARDING THE CURRENT HEADER. NO ADVERSE PATIENT EFFECTS WERE 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 61 YR Required Intervention 4046| 4591| N119| 0185| (B)(4)