BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2051793 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-04246
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 21, 2011
    Report Date
    March 9, 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 TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    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. ANALYSIS COULD NOT DETERMINE A REASON FOR THE REPORTED CLINICAL OBSERVATION OF DISLODGEMENT. 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. IN ADDITION, THE PROXIMAL END OF THE DISTAL SPRING ELECTRODE IS SEPARATED FROM THE LEAD BODY INSULATION HOWEVER MEDICAL ADHESIVE WAS PRESENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT ONE MONTH POST IMPLANT, THIS RIGHT VENTRICULAR LEAD DISPLAYED INCREASED THRESHOLD MEASUREMENTS AND LOSS OF CAPTURE. LEAD DISLODGEMENT WAS SUSPECTED. ALL OTHER LEAD MEASUREMENTS WERE WITHIN NORMAL LIMITS. A DECISION WAS MADE TO REPLACE THIS LEAD. A REVISION PROCEDURE WAS PERFORMED, THIS 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
    1 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0285

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention