BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2041709 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-01053
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 13, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    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 PRODUCT WAS PART OF A SYSTEM EXPLANT DUE TO A (B)(6) INFECTION. DURING THE PROCEDURE THE HELIX WOULD NOT RETRACT. THE PHYSICIAN SUSPECTED HE MADE A CUT THROUGH THE SILICONE OF THE LEAD AND THE COIL EJECTED FROM BOTH COILS. EVENTUALLY THE LEAD BROKE AT THE PROXIMAL END OF THE DISTAL COIL. THE COIL-TO-TIP OF THIS LEAD REMAINED FLOATING IN THE SUPERIOR VENA CAVA. A CATHETER WAS PLACED THROUGH THE FEMORAL LEAD AND THE LEAD WAS REMOVED EXCEPT A CENTIMETER OF THE LEAD TIP WHICH REMAINED IN THE MYOCARDIUM. THE PHYSICIAN WAS OK WITH THIS AND DOES NOT SUSPECT A LEAD MALFUNCTION. THIS LEAD WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THE PATIENT EXPERIENCED A DROP IN BLOOD PRESSURE WHILE TUGGING ON THE LEAD. THE PATIENT WAS REPORTED AS STABLE FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Life Threatening| R (B)(4)| (B)(4)| (B)(4)