BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2882031 · Received December 20, 2012

    Report

    Report Number
    2124215-2012-17140
    Event Type
    Death
    Date Received
    December 20, 2012
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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 A LEAD FRACTURE WAS SUSPECTED. THE LEAD WAS EXHIBITING INCREASED THRESHOLD MEASUREMENTS, HOWEVER, IMPEDANCE AND SENSING MEASUREMENTS WERE STABLE. A LEAD REVISION WAS SCHEDULED. DURING THE PROCEDURE, THE SUPERIOR VENA CAVA WAS PERFORATED WHEN ATTEMPTING TO EXTRACT THE LEAD. EMERGENCY MEASURES WERE ATTEMPTED INCLUDING OPENING THE PATIENT'S CHEST AND PLACING THEM ON CARDIOPULMONARY BYPASS. THE PATIENT HOWEVER EXPIRED ON THE TABLE. NO PRODUCTS WILL BE RETURNED. ADDITIONAL INFORMATION WAS OBTAINED FROM THE FIELD THAT NO OBVIOUS LEAD FRACTURE WAS OBSERVED UNDER FLUOROSCOPY. NO OTHER OUT OF RANGE LEAD MEASUREMENTS WERE NOTED. IT APPEARS THE COMPETITOR DEVICE WAS ALSO BEING REPLACED DURING THE PROCEDURE FOR ELECTIVE REPLACEMENT INDICATOR. SINCE THE LEAD WAS NOT EXPLANTED, NO FURTHER EXAMINATION WAS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death 0175| MISMATCH| T165