BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYFLEX

    MDR report key: 1962288 · Received January 18, 2011

    Report

    Report Number
    2124215-2011-00964
    Event Type
    Injury
    Date Received
    January 18, 2011
    Date of Event
    October 26, 2010
    Report Date
    January 18, 2011
    Manufacturer
    GUIDANT ANGLETON/ST. PAUL
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED INFORMATION PROVIDED NOTED THAT REASON THIS LEAD WAS REPLACED WAS DUE TO THE PHYSICIAN WANTING AN IS-1 CONNECTOR WHEN IMPLANTING A NEW DEVICE. THIS LEAD WAS CAPPED AND LEFT IN THE PATIENT.

    Additional Manufacturer Narrative · 1

    UPON ADDITIONAL INFORMATION THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT LEAD FAILURE WAS ALLEGED. NO PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYFLEX IMPLANTABLE LEAD NVN GUIDANT ANGLETON/ST. PAUL 486-01

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR (B)(4)| (B)(4)| (B)(4)| 1198| 4471| S601