BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCUNET EMBOLIC PROTECTION SYSTEM

    MDR report key: 856583 · Received May 25, 2007

    Report

    Report Number
    3004742046-2007-00178
    Event Type
    Injury
    Date Received
    May 25, 2007
    Date of Event
    September 1, 2006
    Report Date
    May 3, 2007
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    NTE
    PMA / PMN Number
    K052166
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RX ACCULINK PART #1011344-40, LOT #5081551, REFERENCED IN D11 IS BEING FILED UNDER MFR #3004742046-2007-00169. THE DEVICE WAS NOT RETURNED, HOWEVER, THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT IS FORTHCOMING. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH ANY RELEVANT INFO.

    Description of Event or Problem · 1

    STUDY EVENT. DEVICE MALFUNCTION: NONE. SYMPTOMS/AE: MILD RIGHT ARM AND LEG WEAKNESS. TIME OF SYMPTOMS/AE: DURING PROCEDURE AND POST PROCEDURE. IT WAS REPORTED THAT THE PT EXPERIENCED A LEFT HEMISPHERIC TIA PRE-DEPLOYMENT OF THE EMBOLIC PROTECTION DEVICE. THE CONDITION RESOLVED WITHIN 4-6 HOURS. POST-OPERATIVE NEUROLOGIC EVALUATION REVEALED MILD RIGHT ARM AND LEG WEAKNESS. THE CONDITION IS CONTINUING TO IMPROVE. NO ADD'L INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCUNET EMBOLIC PROTECTION SYSTEM NFA NTE GUIDANT ENDOVASCULAR SOLUTIONS NA 5102651

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Disability STENT: RX ACCULINK