BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3951185 · Received July 22, 2014

    Report

    Report Number
    2124215-2014-12832
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    April 30, 2014
    Report Date
    June 4, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    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 PARTIALLY REMOVED AS THE BOTTOM PART REMAINED IN THE PATIENT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE RV LEAD HAD INSULATION DEFECTS AND HAD TO BE REMOVED. HOWEVER, DURING THE LASER LEAD EXTRACTION THE ELECTRODE WAS DAMAGED AND SEPARATED IN TWO PIECES. THE PATIENT WAS SCHEDULED FOR A SECOND PROCEDURE FOR REMOVAL OF THE REMAINING RV LEAD AND IMPLANT OF ANOTHER SYSTEM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428011 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R 4470| 1861| 0148| T165