BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3211354 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07823
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 2, 2013
    Report Date
    June 13, 2013
    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 TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL OBSERVATION REVEALED BLOOD/BODY FLUID NOTED THROUGHOUT THE HELIX MECHANISM. THE HELIX WAS RETRACTED. THE LEAD TIP AND HELIX WERE INTACT AND UNDAMAGED. 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. ANALYSIS DID NOT REVEAL ANY VISIBLE MANUFACTURING ISSUE THAT WOULD HAVE CONTRIBUTED TO THE LEAD DISLODGEMENT.

    Description of Event or Problem · 1

    - -

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT APPROXIMATELY TWO WEEKS POST IMPLANT, FOLLOW UP OF THIS RIGHT VENTRICULAR LEAD REVEALED DECREASED SENSING MEASUREMENTS. IT WAS THOUGHT THIS LEAD MAY BE DISLODGED. A REVISION PROCEDURE WAS PERFORMED. DESPITE ATTEMPTS TO REPOSITION, ACCEPTABLE MEASUREMENTS COULD NOT BE OBTAINED. A DECISION WAS MADE TO REMOVE AND REPLACE THIS LEAD. POST REPLACEMENT, ACCEPTABLE MEASUREMENTS WERE OBTAINED. SUCCESSFUL DEFIBRILLATION THRESHOLD (DFT) TESTING WAS PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311765 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0296

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R