BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2910893 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15838
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    November 19, 2012
    Report Date
    November 19, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISE ON THE PACE/SENSE CHANNEL WHICH WAS OVERSENSED AND RESULT IN INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) THERAPY. IT WAS ALSO REPORTED THAT THE PACING IMPEDANCES HAVE DECREASED TO LESS THAN 200 OHMS. THE PATIENT UNDERWENT A REVISION PROCEDURE AND FURTHER TESTING INDICATES A LEAD ISSUE. THE PATIENT WAS UNABLE TO HAVE A NEW RV LEAD PLACED AS THEY WERE OCCLUDED. THE PATIENT IS SCHEDULED SEPARATE REVISION PROCEDURE AT A LATER DATE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18670 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| L| R 0184| E102| E141