BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 2202979 · Received August 11, 2011

    Report

    Report Number
    2182208-2011-01226
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 2, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P820003/S70
    Removal / Correction Number
    ASKU
    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. (B)(4): WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. EVALUATION SUMMARY: (B)(4): NO ANOMALIES WERE FOUND. HOWEVER, ANALYSIS FOUND THAT A BREAK IN THE PATIENT CABLE WAS CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) WAS NOT PACING. THE EPG WAS REPLACED, SENT FOR REPAIR AND RETURNED TO THE CUSTOMER. THE CABLE WAS TAKEN OUT OF SERVICE. 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. 5433V ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other