BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1863752 · Received October 11, 2010

    Report

    Report Number
    2124215-2010-16540
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    July 30, 2010
    Report Date
    July 30, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS, BOSTON SCIENTIFIC CRM CANNOT CONFIRM THE CLINICAL OBSERVATION. THERE IS NO ADDITIONAL INFORMATION RELATED TO THIS EVENT AVAILABLE, OR TO THE COMPANY AT THIS TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THE REPORT WILL BE UPDATED AS NECESSARY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A ROUTINE VISIT THREE MONTHS POST IMPLANT, THIS RIGHT VENTRICULAR (RV) LEAD DISPLAYED NOISE ON THE VENTRICULAR RATE/SENSE AND SHOCK CHANNELS, WHICH WAS REPRODUCIBLE WITH MANIPULATION. NO CAPTURE WAS OBSERVED AT MAXIMUM PROGRAM OUTPUTS. A LEAD DISLODGEMENT IS SPECULATED. THE PHYSICIAN ADVISED THE PATIENT TO HAVE A REVISION PROCEDURE PERFORMED TO ADDRESS THE RV LEAD, BUT THE PATIENT REFUSED UNTIL A LATER DATE. THE PATIENT IS NOT DEPENDENT WITH AN UNDERLYING RHYTHM, AND THE LEAD PROGRAMMING WAS MODIFIED TO MAXIMUM RV OUTPUT. ADDITIONAL ADJUSTMENTS WERE MADE TO THE DEVICE TO AVOID ANY UNINTENTIONAL THERAPY DELIVERY DUE TO THE CONDITION OF THIS LEAD. A SAVE TO DISK WAS PERFORMED AND ANALYZED BY BOSTON SCIENTIFIC TECHNICAL SERVICES (TS). HIGH THRESHOLD VALUES WERE OBSERVED, AND CONFIRMED THE LOSS OF CAPTURE. THE IMPEDANCE MEASUREMENTS ARE VARIABLE WITH A RANGE OF 1200-1950OHMS. NUMEROUS NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) EPISODES OCCURRED SINCE IMPLANT, ALTHOUGH ONLY TWO EPISODES RETAINED DETAILS. THE AMPLITUDE SENSING IS STABLE, ALTHOUGH LESS THAN IMPLANT, AND NO INHIBITION HAS OCCURRED. NOISE WAS NOT DISPLAYED ON THE SHOCK CHANNEL, AND IMPEDANCE VALUES WERE NORMAL. TS SUPPORTED THE POSSIBILITY OF A DISLODGEMENT OR INADEQUATE LEAD TIP/TISSUE CONTACT AND RECOMMENDED THAT A REVISION BE PERFORMED TO ADDRESS THIS LEAD ISSUE. THE PATIENT DID NOT SHOW UP FOR HIS SCHEDULED REVISION PROCEDURE, AND NO ADVERSE EFFECTS WERE REPORTED. APPROXIMATELY THREE WEEKS LATER, THE REVISION PROCEDURE WAS PERFORMED, AND THE LEAD WAS EXPLANTED. THE PHYSICIAN REPORTED OBSERVED NECROSIS OF THE INFARCT INVOLVED IN THE APEX, WHICH MAY HAVE ATTRIBUTED TO NONSTIMULATION BY THE LEAD. THE NEW LEAD WAS SUCCESSFULLY IMPLANTED INTO THE MIDDLE SEPTUM, AND THE CHRONIC LEAD WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0286

    Patients

    Seq Age Sex Outcome Treatment
    1