BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2040128 · Received April 5, 2011

    Report

    Report Number
    2124215-2011-01108
    Event Type
    Injury
    Date Received
    April 5, 2011
    Date of Event
    January 4, 2011
    Report Date
    March 27, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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

    ADDITIONAL INFORMATION RECEIVED FROM THE LOCAL SALES REPRESENTATIVE STATES THAT THIS LEAD WAS REMOVED FROM SERVICE DUE TO AN EROSION/INFECTION. NO OTHER ADVERSE PATIENT EFFECTS REPORTED FROM THE PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT IT WAS OBSERVED THIS LEAD HAD ERODED THROUGH THE SKIN. AS THE SITE WAS NOT OBVIOUSLY RED OR SWOLLEN AND THE PATIENT BEING PACER DEPENDENT, THE PHYSICIAN OPTED TO DO SOME BACTERIAL CULTURES AND BURY THE LEADS AND PACEMAKER SUBPECTORALLY TO PREVENT FURTHER EROSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Hospitalization| L| R (B)(4)| (B)(4)| (B)(4)| (B)(4)