BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 2202964 · Received August 11, 2011

    Report

    Report Number
    2183613-2011-00366
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    May 9, 2011
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S70
    Removal / Correction Number
    Z-1661-2014
    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. EVALUATION SUMMARY: (B)(4): ANALYSIS FOUND THAT THE FLEXIBLE TAPE WAS OUT OF SPECIFICATION AND THE CONTACT FOR THE CONNECTOR WAS OUT OF SPECIFICATION.

    Additional Manufacturer Narrative · 1

    APPROXIMATELY 6 WEEKS AGO, A FIELD CORRECTIVE ACTION WAS INITIATED FOR THE SUSPECT MEDICAL DEVICE NOTED IN SECTION D WHICH MAY INVOLVE INTERMITTENT PERFORMANCE OF CERTAIN PACING FUNCTIONS..

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE EXTERNAL PULSE GENERATOR (EPG) WAS BEING USED, WITH A RATE SETTING OF 50 BPM, A 110 BPM PACING RATE WAS CONFIRMED ON AN ELECTROCARDIOGRAM. THE DEVICE WAS RETURNED FOR SERVICING. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASKU PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE DTE MEDTRONIC MILACA INC. 5348 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R