BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2790144 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03378
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    July 27, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS STANDING UP FOR THE MEASUREMENT OF BODY WEIGHT AND "PACING FAILURE" OCCURRED. IT WAS ALSO REPORTED THE PACING STOP THAT OCCURRED SUDDENLY WAS DUE TO DISENGAGEMENT OF THE PATIENT CABLE FROM THE RELATED EXTERNAL PACEMAKER. PATIENT CABLE WAS PLUGGED INTO DEVICE AND PACING WAS RESUMED. 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, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention