BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1850049 · Received October 1, 2010

    Report

    Report Number
    2124215-2010-14499
    Event Type
    Injury
    Date Received
    October 1, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 1, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS PATIENT EXPERIENCED SYNCOPE AND WENT TO THE HOSPITAL. THE PHYSICIAN REVIEWED THE DEVICE ELECTROGRAMS (EGMS) AND NOTED SEVERAL EPISODES OF OVERSENSING DUE TO NOISE. X-RAY ANALYSIS OF THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) SYSTEM REVEALED ANOMALIES ON THE LEAD ELECTRODE. THE REPORT DID NOT DISTINGUISH WHICH LEAD ELECTRODE WAS AFFECTED. THE NEXT DAY, A NEW NON-BOSTON SCIENTIFIC SYSTEM WAS IMPLANTED, AND THIS CRT-D ALONG WITH THE CHRONIC LEADS WERE EXPLANTED WITHOUT FURTHER INCIDENT. THE DEVICE WILL BE RETURNED AND THE LEADS WERE DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R