BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2173805 · Received July 24, 2011

    Report

    Report Number
    2124215-2011-10755
    Event Type
    Injury
    Date Received
    July 24, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 21, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF NEW INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTED SYSTEM WAS EXPLANTED DUE TO INFECTION. THE SYSTEM HAD BEEN IMPLANTED FOR APPROXIMATELY (B)(6) AND NO EXPLANTED PRODUCT IS INTENDED TO RETURNED. TO DATE, NO INFORMATION COMMUNICATED REGARDING FUTURE IMPLANTS.

    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 82 YR Required Intervention (B)(4)| (B)(4)| (B)(4)