BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2041660 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00944
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    December 26, 2010
    Report Date
    March 4, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. RESISTANCE AND PRESSURE TESTS WERE THEN COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. ALL MEASUREMENTS WERE WITHIN NORMAL LIMITS INDICATING CONDUCTOR AND INSULATION CONTINUITY. INSPECTION OF THE LEAD REVEALED A SEPARATION OF THE GORE COVERING FROM THE MEDICAL ADHESIVE (MA) AT THE PROXIMAL EDGE OF THE PROXIMAL SHOCKING COIL. ASSOCIATED WITH THIS WAS A SLIGHT STRETCHING OF THE PROXIMAL END OF THIS SHOCKING COIL. THE SEPARATION WAS A RESULT OF EXCESSIVE DRAG ON THE GORE AND THE SHOCKING COILS. THE CLINICAL OBSERVATION COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    THIS LEAD WILL BE RETURNED. UPON ANALYSIS THIS PI WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT IT WAS NOT POSSIBLE TO IMPLANT THIS RIGHT VENTRICULAR (RV) LEAD DUE TO THE PATIENTS ANATOMY. ATTEMPTING TO POSITION THE RV LEAD TO OBTAIN NORMAL MEASUREMENTS WAS NOT POSSIBLE AND IT WAS ALLEGED THAT THE RV LEAD DISLODGED. THE PROCEDURE WAS FINISHED WITH ANOTHER LEAD SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1