BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELECT SECURE

    MDR report key: 1951692 · Received January 6, 2011

    Report

    Report Number
    2182208-2011-00008
    Event Type
    Injury
    Date Received
    January 6, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVN
    PMA / PMN Number
    P030036
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: "PERFORMANCE OF THE LUMENLESS 4.1-FR DIAMETER PACING LEAD IMPLANTED AT ALTERNATIVE PACING SITES IN CONGENITAL HEART: A CHRONIC 5-YEAR COMPARISON." PACING AND CLINICAL ELECTROPHYSIOLOGY: PACE.33(12):1467-1474.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS LEAD. THE ARTICLE INDICATED THAT THE LEAD HAD DISLODGED AND WAS REPOSITIONED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELECT SECURE IMPLANTABLE PACING LEAD NVN MEDTRONIC, INC. 3830 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R