BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 2051211 · Received April 12, 2011

    Report

    Report Number
    2183613-2011-00083
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    January 28, 2011
    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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. 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.

    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. NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) "FROZE" DURING THE PACING, BUT THE EPG CONTINUED THE NORMAL OPERATION. THE EPG WAS EXCHANGED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR WAS FROZEN DURING THE PACING, BUT THE EXTERNAL PULSE GENERATOR OPERATED NORMAL. THE EXTERNAL PULSE GENERATOR WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN 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 Hospitalization| O| R