BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2791204 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01699
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    July 5, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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. EVALUATION SUMMARY (B)(4): THE EXTERNAL PULSE GENERATOR WAS RETURNED AND ANALYSIS DID CONFIRM THE CUSTOMER COMMENT THAT THE VENTRICULAR OUTPUT CONNECTOR WAS BROKEN. ANALYSIS ALSO FOUND THAT BOTH BAIL COVERS WERE BROKEN AND THAT THE KEYBOARD WAS SCRATCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIM OF THE CONNECTION POINT ON TOP OF THE PACING BOX OF THE EXTERNAL PULSE GENERATOR WAS MISSING, MAKING IT IMPOSSIBLE TO CONNECT THE WIRE. THE GENERATOR WAS RETURNED FOR SERVICE AND CALIBRATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other