BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3912935 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-13462
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    May 22, 2014
    Report Date
    July 7, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. MICROSCOPIC INSPECTIONS OF THE TERMINAL PIN ASSEMBLY, LEAD BODY, AND ELECTRODE TIP FOUND NO ANOMALIES. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS AND DETAILED ANALYSIS DID NOT REVEAL ANY ABNORMALITIES.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT PRESENTED WITH COMPLAINTS OF CHEST DISCOMFORT. AN INTERROGATION REVEALED HIGH RIGHT VENTRICULAR (RV) LEAD THRESHOLD MEASUREMENTS. AN ECHOCARDIOGRAM WAS DONE AND REVEALED A SMALL EFFUSION. NO PERFORATION WAS OBSERVED ON THE ECHOCARDIOGRAM. THE PATIENT IS NOT PACEMAKER DEPENDENT AND THERE WAS NO LOSS OF CAPTURE DUE TO THE HIGH THRESHOLD MEASUREMENTS. THE PATIENT HAD A COMPUTERIZED TOMOGRAPHY (CT) SCAN AND NO PERFORATION WAS NOTED THERE EITHER, THUS THE CAUSE OF THE PERICARDIAL EFFUSION REMAINED UNKNOWN. NO PROGRAMMING CHANGES WERE MADE TO THE SYSTEM DUE TO THE EFFUSION, HOWEVER THE PATIENT IS ALSO BEING TREATED FOR PERICARDITIS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE RV LEAD WAS EXPLANTED FOR INCREASED THRESHOLD MEASUREMENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391407 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| L| R E162| 5076| 0295