BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2791168 · Received October 15, 2012

    Report

    Report Number
    2182208-2012-03286
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 4, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Removal / Correction Number
    Z-0430-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 DEVICE WAS ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THE EPG (EXTERNAL PULSE GENERATOR) WAS USED FOR THE PATIENT IN THE HOSPITAL ROOM. WHEN THE TRANSFER OF THE PATIENT WAS MADE, THE EPG TURNED OFF SUDDENLY AND STOPPED. AFTER THE BATTERY WAS REPLACED AND THE SWITCH WAS ON, THE EPG STARTED AGAIN. IT WAS REPORTED THAT THE LOW BATTERY INDICATOR WAS NOT SHOWN. THE EPG WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE 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 Other