BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3052682 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-03746
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    February 5, 2013
    Report Date
    April 5, 2013
    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, RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. VISUAL 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. UNDER NORMAL CIRCUMSTANCES, SEPARATION OF THE GORE COVERING WILL NOT IMPACT THE FUNCTIONALITY OF THE LEAD.

    Additional Manufacturer Narrative · 1

    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 DURING AN IMPLANT PROCEDURE, THIS RIGHT VENTRICULAR (RV) LEAD WAS INSERTED INTO THE PATIENT WITH A PEAL AWAY INTRODUCER. DURING MANIPULATION OF THE LEAD INSULATION DAMAGE WAS OBSERVED BY THE PHYSICIAN. IT WAS NOTED THAT THE SHOCKING COIL APPEAR TO BE STRETCHED AND BLOOD ENTERED INTO THE LEAD. THE LEAD WAS REMOVED, REPLACED AND RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154681 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1