BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3213042 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10373
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 26, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD REMANS IN SERVICE. 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 INCREASED PACING THRESHOLD MEASUREMENTS, TO 3.2V. THE LEAD WAS REPOSITIONED DURING THE PROCEDURE TO ADDRESS THE PATIENT'S HEMATOMA. THE LEAD WAS CHECKED WITH THE PACING SYSTEM ANALYZER (PSA) AND THE THRESHOLD MEASUREMENTS WERE UNSTABLE, ESPECIALLY DURING DEEP BREATHING. A LEAD DISLODGEMENT WAS SUSPECTED. THE LEAD WAS SUCCESSFULLY REPOSITIONED WITH GOOD MEASUREMENTS OBTAINED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314347 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0286

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| L| R 0286| P162| 4543| 4592