BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3913586 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-13404
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 23, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 HAD DISLODGED. THE RV LEAD WAS SURGICALLY ABANDONED AND WAS SUCCESSFULLY REPLACED WITH A NEW COMPETITOR RV LEAD. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390856 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0165

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 0165| 4480| MISMATCH| T167