BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3212472 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-08527
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 18, 2013
    Report Date
    May 19, 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

    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 WAS FRACTURED AS AN X-RAY REVEALED SEPARATION IN THE LEAD BODY. IT WAS REPORTED THAT A RED ALERT WAS DECLARED THROUGH THE PATIENT MONITORING SYSTEM FOR LOW RV PACE IMPEDANCES LESS THAN 200 OHMS. THE PATIENT WAS EVALUATED IN THE OFFICE. NOISE WAS ABLE TO BE RECREATED WITH ISOMETRICS. IT WAS ALSO REPORTED THAT THE PATIENT HAD RECEIVED AN INAPPROPRIATE SHOCK EARLIER DUE TO NOISE AND OVERSENSING. THERE WAS NO ASYSTOLE OR ADVERSE PATIENT EFFECTS. THE PATIENT UNDERWENT A REVISION PROCEDURE AND THIS PRODUCT WAS SURGICALLY CAPPED AND ABANDONED. A NEW LEAD WAS SUCCESSFULLY PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314268 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R E110| 4470| 0184