BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2151191 · Received July 6, 2011

    Report

    Report Number
    2124215-2011-07576
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    April 1, 2011
    Report Date
    August 9, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION WAS RECEIVED THAT THE PATIENT HAD DIED OF AN UNSPECIFIED CAUSE AND THE PRODUCT IS THEREFORE NO LONGER IN SERVICE. THERE IS NO EVIDENCE OR ALLEGATION THE REPORTED OBSERVATIONS CONTRIBUTED TO THE PATIENT DEATH. THE PRODUCT IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    TO DATE, INFORMATION SUGGESTS THAT THIS RV LEAD REMAINS ACTIVELY IMPLANTED BUT WAS SCHEDULED FOR IMMINENT SURGICAL INTERVENTION. AS NEW INFORMATION WOULD BECOME AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD DID EXHIBIT NOISE, THAT WERE EVIDENT IN TWO NON-SUSTAINED VENTRICULAR TACHYCARDIA (NSVT) EPISODES LASTING BETWEEN 2-3 SECONDS EACH. SENSING WAS NOTED AS DEGRADING FROM 10 TO 4.7MV, ALSO THAT IMPEDANCES WERE RISING, AND ALSO THRESHOLDS. THE PATIENT RECEIVED INAPPROPRIATE CHOCK AS A RESULT. THE PHYSICIAN SCHEDULED A LEAD CHANGE OUT. THERE WAS INDICATION OF ADVERSE PATIENT SYMPTOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0147

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention 0147| 1860