BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 1921099 · Received December 13, 2010

    Report

    Report Number
    2182208-2010-00918
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 9, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P820003/S70
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. EVALUATION SUMMARY: (B)(4) NO ANOMALIES WERE FOUND. (B)(4) - ANALYSIS CONFIRMED A CONDUCTOR FRACTURE OF THE PATIENT CABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PACING FAILURE OCCURRED WHEN THE DEVICE WAS CONNECTED TO A PATIENT. THE PATIENT WAS NOT PACER DEPENDENT. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASKU INSTRUMENT CABLE DTB MEDTRONIC, INC. 5433A ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other