BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASKU

    MDR report key: 1922458 · Received December 13, 2010

    Report

    Report Number
    2183613-2010-00319
    Event Type
    Injury
    Date Received
    December 13, 2010
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 COULD NOT CONFIRM THE REPORTED EVENT. THE DEVICE PASSED TESTING, WITH NO ANOMALIES FOUND. THE BATTERY CONTACTS WERE CONTAMINATED, AND THE BAIL ATTACHMENT COVERS WERE BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE SHOWED A BLANK SCREEN, WITH NO PRIOR WARNING OF A LOW BATTERY. THE ECG MONITOR ALARMED, ALERTING HOSPITAL STAFF TO A HEART RATE OF 50BPM AND REDUCED SYSTOLIC PRESSURE. THE DEVICE WAS SET TO DDD, WITH A LOWER RATE OF 90PPM. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASKU EXTERNAL PULSE GENERATOR DTE MEDTRONIC MILACA INC. 5388 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other