BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3921718 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-13595
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    February 11, 2014
    Report Date
    May 20, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT IS 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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD AND A COMPETITOR'S DEVICE EXHIBITED A RISING SHOCK IMPEDANCE FROM 44 TO 120 OHMS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) RECOMMENDED TO DO A COMMANDED SHOCK AND X-RAY FOR CONFIRMATION. ADDITIONAL INFORMATION RECEIVED THAT HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT OF 130 OHMS WAS OBSERVED ON THIS SYSTEM. ADDITIONAL INFORMATION RECEIVED THAT THE CAUSE WAS NOT CONCLUSIVELY DETERMINED; HOWEVER, A LEAD CRUSH WAS SUSPECTED. THE RV LEAD WAS SURGICALLY ABANDONED AND THE DEVICE WAS EXPLANTED DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400081 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| L| R 0184| T165| 5076