BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATTAIN HYBRID ADJUSTABLE SLITTER

    MDR report key: 3992558 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02384
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DRB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS EVENT OCCURRED OUTSIDE THE US AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE SALES REPRESENTATIVE NOTICED THE SLITTER WAS ONE DAY BEYOND ITS USE-BEFORE-DAT E. THE PHYSICIAN DECIDED TO USE THE SLITTER FOR THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472417 ATTAIN HYBRID ADJUSTABLE SLITTER STYLET, CATHETER DRB MEDTRONIC, INC. 6232ADJ 46120012

    Patients

    Seq Age Sex Outcome Treatment
    1