BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4140211 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-16874
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 4, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 LOCAL REPRESENTATIVE CONTACTED BOSTON SCIENTIFIC'S TECHNICAL SERVICES (TS). THE LOCAL REPRESENTATIVE WAS CONTACTED BY THE PHYSICIAN WHO REPORTED THAT THIS PATIENT WAS PRESENTED BACK TO THE ELECTROPHYSIOLOGY (EP) LABORATORY. THE DEVICE AND LEAD SYSTEM (BOSTON SCIENTIFIC AND COMPETITOR LEADS) WERE EXPLANTED DUE TO INFECTION. THE PATIENT HAD BEEN ADMITTED INTO THE HOSPITAL FOUR DAYS PRIOR TO THE EXPLANT PROCEDURE WITH COMPLAINTS OF FEVER. THE POCKET SITE WAS REDDEN AND AN INFECTION AT THE POCKET SITE WAS SUSPECTED. THE PATIENT IS NOT PACEMAKER DEPENDENT. THE PHYSICIAN PLANS TO TREAT THE PATIENT WITH MEDICATION AND DETERMINE WHEN THE REPLACEMENT PROCEDURE WILL SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619554 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R MISMATCH| 5076| G156| 0185