BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3910430 · Received July 2, 2014

    Report

    Report Number
    2124215-2014-09465
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PHYSICIAN

    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 THE SUTURE SLEEVE ON THIS RIGHT VENTRICULAR (RV) LEAD WAS LEFT IN THE PATIENT¿S VEIN. A CEPHALIC CUTDOWN WAS PERFORMED; HOWEVER, THE PHYSICIAN COULD NOT RETRIEVE IT. IT IS NOTED THAT THE TERMINAL END OF THE RV LEAD WAS MORE LUBRICIOUS AND ITS SUTURE SLEEVE SLIP OFF EASILY THAN WITH OTHER LEADS. THE PHYSICIAN OPTED TO KEEP THE RV LEAD AND ADDED ANOTHER SUTURE SLEEVE TO TIE THE LEAD DOWN. THE RV LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388657 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0293

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R E140| 0293