BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3040773 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00174
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 2, 2013
    Report Date
    January 25, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. VISUAL INSPECTION NOTED THERE WAS A PARTIAL ABRASION IN THE TRILUMEN INSULATION, BUT THERE WERE NO CONDUCTORS EXPOSED. THE PARTIAL ABRASION WAS LIKELY DUE TO LEAD-ON-LEAD CONTACT. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. 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 DURING A ROUTINE FOLLOW-UP APPOINTMENT, NOISE WAS NOTED ON THE VENTRICULAR CHANNEL AS WELL AS THE SHOCK CHANNEL. THE NOISE RESULTED IN OVERSENSING. NO INHIBITION OF PACING RESULTED FROM THE OVERSENSING AS THE PATIENT WAS NOT DEPENDENT. TESTING WAS PERFORMED AND THE NOISE WAS REPRODUCED. A FRACTURE AND INSULATION DAMAGE WAS SUSPECTED DUE TO SUBCLAVIAN CRUSH. A REVISION PROCEDURE WAS SCHEDULED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT THE LEADS WERE EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144123 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L