BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1980988 · Received February 8, 2011

    Report

    Report Number
    2124215-2011-02174
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    November 17, 2010
    Report Date
    November 17, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THESE MEDICAL DEVICE REMAIN ACTIVELY IN SERVICE. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, INVESTIGATION IS CONSIDERED COMPLETE. THIS REPORT WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD IN ASSOCIATION WITH THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILATOR (CRT-D) DID EXHIBIT PROBABLE R-WAVE UNDERSENSING ASSOCIATED WITH PHYSIOLOGICALLY SMALL R-WAVE AMPLITUDE WITHIN THE VENTRICULAR FIBRILLATION THAT OCCURRED. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED, BUT THERE WERE THREE BEATS OF UNDERSENSING OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR H227| (B)(4)| 4555| 0185