BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4131452 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14973
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 7, 2014
    Report Date
    November 18, 2014
    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

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT WAS NEVER RETURNED FROM THE FIELD FOR ANALYSIS. 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

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP, THIS RIGHT VENTRICULAR (RV) LEAD WAS FOUND TO HAVE HIGH THRESHOLDS AND EXHIBITED A DROP IN SENSING. AN X-RAY REVEALED THAT THE LEAD HAD DISLODGED. ADDITIONAL INFORMATION FROM THE FIELD REVEALED THAT A REVISION PROCEDURE WAS PERFORMED AND THE PHYSICIAN TRIED TO REPOSITION THE RV LEAD MULTIPLE TIMES WITH NO SUCCESS. TISSUE WAS NOTED IN THE HELIX AND IT WAS DECIDED TO EXPLANT AND REPLACE THE LEAD. THE RV LEAD IS NO LONGER IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION MADE AVAILABLE FROM THE FIELD INDICATED THAT DURING THE REPLACEMENT PROCEDURE THE PHYSICIAN FELT THAT THE HELIX OF THE RV LEAD WAS DAMAGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610458 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| L| R E160| 0293