BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 2203394 · Received August 11, 2011

    Report

    Report Number
    2182208-2011-01232
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 6, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DQX
    PMA / PMN Number
    ASKU
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT, THE PHYSICIAN HAD DIFFICULTY THREADING A "WHISPER WIRE" DOWN THE LEAD. IT MET RESISTANCE AT A FEW POINTS WHILE WORKING ITS WAY DOWN THE LEAD. PATIENT DID NOT HAVE PARTICULARLY TORTUOUS ANATOMY. EVENTUALLY, THE PHYSICIAN WAS ABLE TO USE THE WIRE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASKU GUIDE WIRE DQX MEDTRONIC, INC. GUIDEWIRE ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other