BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2170434 · Received July 21, 2011

    Report

    Report Number
    2124215-2011-12112
    Event Type
    Death
    Date Received
    July 21, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 7, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO ADDITIONAL INFORMATION CONCERNING THIS REPORT IS EXPECTED AT THIS TIME, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION FROM A BOSTON SCIENTIFIC FIELD REPRESENTATIVE THAT A HEALTH CARE PROVIDER (HCP) REPORTED THIS PATIENT PASSED AWAY DURING THE ATTEMPTED EXTRACTION OF LEADS FOLLOWING THE ONSET OF A DEVICE POCKET INFECTION. THERE WERE NO ALLEGATIONS AGAINST THIS LEAD OR THE OTHER SYSTEM COMPONENTS. THE HCP NOTED THAT THE DEATH WAS ASSOCIATED WITH THE PATIENT'S BLOOD PRESSURE DROPPING DURING THE SURGICAL PROCEDURE. AN ECHOCARDIOGRAM WAS PERFORMED BUT SHOWED NO EVIDENCE OF AN EFFUSION. THE PRODUCTS SUBSEQUENTLY WERE NOT EXPLANTED.

    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 70 YR Death| R 0185| 4543| N119| 4470