BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 1802792 · Received August 17, 2010

    Report

    Report Number
    2183613-2010-00140
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. NO ELECTRICAL OR VISUAL ANOMALIES WERE OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE EPG (EXTERNAL PULSE GENERATOR) HAD INTERMITTENT PROBLEMS. THE DEVICE WAS SET TO ATRIAL PACE, BUT INSTEAD PACED THE VENTRICLE, AT AN INCORRECT RATE. FOLLOW-UP INFORMATION RECEIVED REPORTED THE DEVICE WAS ATTACHED TO A PATIENT WHEN THE EVENT OCCURRED, BUT THERE WERE NO PATIENT COMPLICATIONS. IT WAS ALSO NOTED THAT IN (B)(6)2010, THE DEVICE WAS NOTED TO HAVE TURNED ITSELF OFF INTERMITTENTLY AND WENT TO A BLANK SCREEN. THE DEVICE WAS TESTED FOR 15 DAYS IN A ROW, BUT NO PROBLEMS WERE OBSERVED. IT WAS RECENTLY DECIDED TO SEND THE DEVICE BACK TO HAVE IT FULLY ANALYZED TO SEE WHAT THE PROBLEM WAS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE EPG (EXTERNAL PULSE GENERATOR) HAD INTERMITTENT PROBLEMS. THE DEVICE WAS SET TO ATRIAL PACE, BUT INSTEAD PACED THE VENTRICLE, AT AN INCORRECT RATE. FOLLOW-UP INFORMATION RECEIVED REPORTED THE DEVICE WAS ATTACHED TO A PATIENT WHEN THE EVENT OCCURRED, BUT THERE WERE NO PATIENT COMPLICATIONS. IT WAS ALSO STATED THAT IN (B)(6) 2010, THE DEVICE WAS NOTED TO HAVE TURNED ITSELF OFF INTERMITTENTLY AND WENT TO A BLANK SCREEN. THE DEVICE WAS TESTED FOR 15 DAYS IN A ROW, BUT NO PROBLEMS WERE OBSERVED. IT WAS RECENTLY DECIDED TO SEND THE DEVICE BACK TO HAVE IT FULLY ANALYZED TO SEE WHAT THE PROBLEM WAS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other