BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2170922 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-09835
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    April 6, 2011
    Report Date
    June 4, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RA AND RV LEAD WERE EXPLANTED. 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 DURING AN IMPLANT PROCEDURE, THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEADS DISLODGED. MULTIPLE ATTEMPTS WERE MADE TO REPOSITION THE LEAD, HOWEVER ATTEMPTS WERE UNSUCCESSFUL AND THE LEADS CONTINUED TO DISLODGE. IT WAS NOTED THAT DURING MANIPULATION OF THE RA LEAD THE RIGHT VENTRICULAR (RV) LEAD WAS HOOKED AND ALSO DISLODGED. WHILE ATTEMPTING TO REGAIN ACCESS THROUGH THE SUBCLAVIAN VEIN A PERFORATION OF THE VESSEL OCCURRED FROM THE RA LEAD. DUE TO THE PATIENT'S ANATOMY THE COLLAR BONE WAS UNABLE TO BE LOCATED AND A DECISION WAS MADE TO IMPLANT A NEW SINGLE CHAMBER DEVICE AND LEADS. THE RA AND RV LEADS WERE UNABLE TO BE IMPLANTED. THE RA AND RV LEAD WILL BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| O