BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2780040 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-11989
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 6, 2012
    Report Date
    September 5, 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

    AS NO RETURN OF PRODUCT IS INTENDED, THIS REPORTED ALLEGATION CANNOT BE CONFIRMED NOR DENIED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT POST IMPLANT OF DEVICE (INCEPTA P163 SN (B)(4)); THIS CHRONIC RIGHT VENTRICULAR LEAD DISPLAYED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS IN TWO PROGRAMMED CONFIGURATIONS. MEASUREMENTS IN RV LEAD TO THE DEVICE WERE WITHIN NORMAL RANGE. IN ADDITION, SHOCK IMPEDANCE MEASUREMENTS WITH THE PACING SYSTEM ANALYZER WERE WITHIN NORMAL LIMITS. WHEN CONNECTED TO THE PREVIOUS DEVICE, (CONTAK RENEWAL H230 SN (B)(4)), NORMAL LEAD MEASUREMENTS WERE OBTAINED. AN X-RAY OF THE LEAD WAS PERFORMED. IT WAS NOTED THE PROXIMAL PART OF THE PROXIMAL COILS WERE STRETCHED. DESPITE FOUR LEADS IMPLANTED, A DECISION WAS MADE TO IMPLANT ANOTHER LEAD. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R