BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RX ACCULINK CAROTID STENT SYSTEM

    MDR report key: 724521 · Received June 8, 2006

    Report

    Report Number
    3004742046-2006-00260
    Event Type
    Injury
    Date Received
    June 8, 2006
    Date of Event
    May 10, 2006
    Report Date
    May 22, 2006
    Manufacturer
    GUIDANT ENDOVASCULAR SOLUTIONS
    Product Code
    NIM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT AND DEVICE CODES IN H10 WERE CODED BY THE MANUFACTURER. INTERNAL FILE NUMBER-82409/1: DURING PROCESSING OF THIS COMPLAINT, QUALITY ASSURANCE ATTEMPTED TO OBTAIN COMPLETE EVENT INFORMATION, INCLUDING PATIENT INFORMATION AND PATIENT STATUS FROM THE HOSPITAL, FIELD CONTACT OR DISTRIBUTOR.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: NONE. SYMPTOMS: BRADYCARDIA, HYPOTENSION. TIME OF SYMPTOMS: DURING THE PROCEDURE ON 5/10/2006 AND STOP DATES WERE 5/13/2006 (BRADYCARDIA) AND 5/12/2006 (HYPOTENSION). IT WAS REPORTED THAT DURING THE PROCEDURE ON 5/10/2006 THE PATIENT EXPERIENCED BRADYCARDIA AND HYPOTENSION. START DATE WAS 5/10/2006 FOR BOTH BRADYCARDIA AND HYPOTENSION AND THE CONDITION IS NOT CONTINUING. THE STOP DATES WERE 5/13/2006 (BRADYCARDIA) AND 5/12/2006 (HYPOTENSION). THE CONDITION WAS NOT PRE-EXISTING. THE ACTION/TREATMENT FOR THE BRADYCARDIA WAS NEOSYNEPHRINE AND FOR THE HYPOTENSION WAS VASOPRESSOR/INOTROPES. THE PATIENT'S OUTCOME FOR BOTH EVENTS WERE RESOLVED. NO ADDITIONAL INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RX ACCULINK CAROTID STENT SYSTEM CAROTID STENT SYSTEM NIM GUIDANT ENDOVASCULAR SOLUTIONS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention