BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THINLINE II STEROX

    MDR report key: 2173197 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-11073
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 21, 2011
    Report Date
    June 16, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM REVISION DUE TO A SUSPECTED INFECTION. THERE WERE NO ADDITIONAL ADVERSE EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THINLINE II STEROX IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4370

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention