BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1771552 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-13007
    Event Type
    Malfunction
    Date Received
    July 27, 2010
    Date of Event
    June 9, 2010
    Report Date
    June 9, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THIS CRT-D AND ASSOCIATED RV LEAD REMAIN ACTIVELY IN SERVICE WITHOUT FURTHER ISSUE. AS NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILATOR (CRT-D) IN ASSOCIATION WITH THE THE RIGHT VENTRICULAR (RV) LEAD HAD OVERSENSED NOISE. THE PATIENT IS PACEMAKER DEPENDENT. PACE INHIBITION HAD OCCURRED OF UP TO 3 SECONDS IN ONE EPISODE. THE PATIENT DID NOT EVER EXPERIENCE SYNCOPE AS A RESULT. THE NOISE WAS NOT REPRODUCIBLE. LEAD DIAGNOSTICS WERE ALL NOTED WITHIN NORMAL LIMITS, BEYOND A SLIGHT RISE IN LEFT VENTRICULAR (LV) THRESHOLD. NO NOISE HAD BEEN OBSERVED ON THE SHOCK CHANNEL. THERE WERE NO REPORTED ADVERSE PATIENT SYMPTOMS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR 1194| 4456| (B)(4)| H210| 0157