BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2781008 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-13330
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 19, 2012
    Report Date
    October 26, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    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 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.

    Additional Manufacturer Narrative · 1

    THIS RIGHT VENTRICULAR (RV) LEAD IS EXPECTED TO BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RECEIPT OF ADDITIONAL INFORMATION, OR WHEN ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD DISLODGED AND SENSED ATRIAL SIGNALS, WHICH LED TO AN INAPPROPRIATE SHOCK. NOISE WAS ALSO NOTED, AS WELL AS LOSS OF CAPTURE. THE LEAD DISLODGEMENT WAS CONFIRMED BY AN X-RAY. THE PATIENT WAS NOT DEPENDENT ON PACING THERAPY, AND THERE WERE NO ADVERSE PATIENT EFFECTS. IT WAS NOTED THAT WHEN THIS LEAD HAD BEEN IMPLANTED IN (B)(6) 2012, IT WAS IMPLANTED IN THE APICAL POSITION AND THERE WERE EIGHT ATTEMPTS TO POSITION THIS LEAD TO FIND GOOD MEASUREMENTS. IT WAS THOUGHT THAT THE HELIX MAY HAVE BEEN DAMAGED DURING THE REPOSITIONING ATTEMPTS AT THE IMPLANT PROCEDURE. THE PATIENT WAS HOSPITALIZED FOR A LEAD REVISION PROCEDURE. DURING THE REVISION PROCEDURE, THE LEAD WAS EASILY REMOVED BY SIMPLY PULLING IT OUT. A NEW RV LEAD WAS IMPLANTED IN THE SEPTAL POSITION WITH NO DIFFICULTIES.

    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 Hospitalization| R