BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1980959 · Received February 8, 2011

    Report

    Report Number
    2124215-2011-02175
    Event Type
    Malfunction
    Date Received
    February 8, 2011
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    INDUCTION WAS REPEATED WITH AUTOMATIC GAIN CONTROL AT 0.6 MILLIVOLTS, AND THE UNDERSENSING ISSUE WAS IMPROVED BUT NOT RESOLVED. ANTI-TACHYCARDIA PACING DID CONVERT THE PATIENT ULTIMATELY. AN INCREASE IN AUTOMATIC GAIN CONTROL STARTING VALUE DID MITIGATE THE ISSUE. BOTH MEDICAL DEVICES REMAIN ACTIVELY IN SERVICE, WITHOUT FURTHER ISSUE. 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 THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) IN ASSOCIATION WITH THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD AT IMPLANT DID EXHIBIT 6 SECONDS OF UNDERSENSING OF VENTRICULAR FIBRILLATION POST-INDUCTION, RESULTING IN SOME INTERMITTENT DELAYS IN THERAPY (INTERMITTENTLY VP AND LIMITED AP, MOSTLY AS). THERE WERE NO ADVERSE PATIENT EFFECTS ASSOCIATED WITH THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0170

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR E110| 4469| 0170