BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2911204 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16545
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 23, 2012
    Report Date
    January 2, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD IS CURRENTLY UNDERGOING ANALYSIS. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE RETURNED SEGMENT OF THE LEAD WAS THOROUGHLY INSPECTED AND ANALYZED. ONLY THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED WHICH HAD BEEN SEVERED 11 CENTIMETERS FROM THE IS-1 PIN. THE RETURNED SEGMENT OF THE LEAD WAS DETERMINED TO HAVE BEEN ELECTRICALLY CONTINUOUS. THE CLINICAL OBSERVATIONS WERE NOT ABLE TO BE CONFIRMED AS ONLY A SMALL PORTION OF THE LEAD WAS RETURNED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD PRESENTED WITH NOISE, OVERSENSING AND INAPPROPRIATE SHOCK THERAPY. THE LEAD WAS REPORTED TO HAVE BEEN FRACTURED. PACING IMPEDANCES WERE GREATER THAN 2000 OHMS AND SHOCK IMPEDANCES WERE GREATER THAN 125 OHMS. THE PATIENT WAS SEEN FOR A LEAD REVISION PROCEDURE WHERE THE LEAD WAS ATTEMPTED TO BE EXPLANTED. DURING THE ATTEMPT, THE LEAD PULLED APART AND THE DISTAL END OF THE LEAD REMAINED IN THE PATIENT'S HEART. A NEW LEAD WAS THEN SUCCESSFULLY IMPLANTED. THE LEAD HAS BEEN RETURNED FOR ANALYSIS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18776 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0157

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R A155| 0157| E110| 4472