BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1851799 · Received October 4, 2010

    Report

    Report Number
    2124215-2010-14096
    Event Type
    Malfunction
    Date Received
    October 4, 2010
    Date of Event
    July 8, 2010
    Report Date
    July 8, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THIS PRODUCT REMAINS IMPLANTED; HOWEVER, DURING THE FOLLOW-UP VISIT, IT WILL BE REEVALUATED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS IMPLANTABLE DEFIBRILLATION LEAD DISPLAYED A RISE IN PACE/SENSE IMPEDANCE MEASUREMENTS SINCE (B)(6) 2009. DURING A RECENT ROUTINE VISIT, THE CURRENT VALUE IS GREATER THAN 2000OHMS, WHERE IT HAS REMAINED STABLE FOR THE PAST WEEK. THE SHOCK IMPEDANCE MEASUREMENT IS STABLE AT 52 OHMS. ALTHOUGH HIGHER THAN IMPLANT VALUES, THE SENSING AND THRESHOLD VALUES ARE ALSO STABLE. THE LOCAL REPRESENTATIVE ADVISED A THREE-MONTH FOLLOW-UP ON THIS LEAD, IN ABSENCE OF ANY PERFORMANCE ANOMALY. THERE WERE NO ADVERSE PATIENT EFFECTS AND THE LEAD WAS REPROGRAMMED TO LENGTHEN THE RECOGNITION WINDOW OF THE VF ZONE BY TWO SECONDS.

    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