BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3213113 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09789
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    GUIDANT PUERTO RICO BV
    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

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR LEAD WAS ABANDONED DUE TO A POCKET INFECTION. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314443 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY GUIDANT PUERTO RICO BV 0148

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| L| R E102| 1860| 0148