BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3053638 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04911
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 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

    THE ABANDONED LEAD WAS NOT RETURNED TO BOSTON SCIENTIFIC THEREFORE, THE CLINICAL OBSERVATIONS COULD NOT BE CONFIRMED. 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 DURING A ROUTINE FOLLOW VISIT, THIS RIGHT VENTRICULAR (RV) LEAD REVEALED A RISE IN PACING IMPEDANCES GREATER THAN 3,000 OHMS. IN ADDITION, A LOSS OF CAPTURE (LOC) OCCURRED FOR AN UNKNOWN DURATION. AN X-RAY WAS TAKEN AND REVEALED NO SIGNS OF A LEAD DISLODGMENT. A REVISION PROCEDURE WAS PERFORMED AND THE PHYSICIAN ELECTED TO ABANDONED THE LEAD AND A NEW RV LEAD WAS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156766 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R