BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2780584 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12660
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 18, 2012
    Report Date
    October 4, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 ONE WEEK FOLLOWING THE IMPLANT PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD WOULD NOT CAPTURE AT 7.5 V. AS A RESULT, THE LEAD WAS SUCCESSFULLY REPOSITIONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED THAT DURING THE REVISION PROCEDURE WHEN THE TIP OF THE LEAD WAS MOVED EVEN A LITTLE BIT, THE THRESHOLD MEASUREMENT WAS VERY BAD. THEREFORE, THE PHYSICIAN SUSPECTED THE ISSUE WAS CAUSED BY MICRO-DISLODGEMENT. MEASUREMENTS WERE APPROPRIATE FOLLOWING THE REVISION PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0292

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R