BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3223597 · Received July 12, 2013

    Report

    Report Number
    2124215-2013-10774
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 27, 2013
    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 VENTRICULAR SENSING ON THIS RIGHT VENTRICULAR (RV) LEAD WAS SET AT 1.6 MV DUE TO THE PATIENT'S CONDITION WITH AUTOMATIC GAIN CONTROL (AGC) AT 0.4 MV DURING IMPLANT. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED NORMAL SENSING VALUES AND THE POSSIBLE CONSEQUENCES TO HAVING A SENSING RATE THAT WAS LOWER THAN NORMAL. CLOSE MONITORING WAS PLANNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD REMAINS IN SERVICE. ADDITIONAL INFORMATION INDICATED THAT THIS RV LEAD HAD DISLODGED TO THE ATRIUM RESULTING TO OVERSENSING AND INAPPROPRIATE SHOCK THERAPY. THE LEAD WAS REPOSITIONED SUCCESSFULLY. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS LEAD REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322305 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0296

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R