BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3052586 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04234
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 7, 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

    BOSTON SCIENTIFIC RECEIVED ADDITIONAL INFORMATION. A REVISION PROCEDURE WAS PERFORMED AND THIS RV LEAD WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS PROCEDURE. THE EXPLANTED LEAD WAS NOT EXPECTED TO BE RETURNED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    AVAILABLE INFORMATION INDICATES THE LEAD REMAINS IMPLANTED BUT DEACTIVATED PENDING A REVISION PROCEDURE. THIS REPORT WILL BE UPDATED WHEN ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP CHECK, THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED UNDERSENSING AND LOSS OF CAPTURE. AN X-RAY WAS PERFORMED, WHICH REVEALED THE LEAD WAS DISLODGED. HIGH, OUT-OF-RANGE PACING IMPEDANCE MEASUREMENTS AND HIGH PACING THRESHOLD MEASUREMENTS WERE ALSO OBSERVED. THE PATIENT WAS HOSPITALIZED AND THE LEAD WAS DEACTIVATED. THE PATIENT WAS NOT PACEMAKER-DEPENDENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156466 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0296

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R