BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2812191 · Received October 31, 2012

    Report

    Report Number
    2182208-2012-03693
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 12, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. EVALUATION SUMMARY: (B)(4) ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UPPER SCREEN ON THE EXTERNAL PULSE GENERATOR DID NOT DISPLAY, THAT THE GENERATOR HAD CORRECT OUTPUTS BUT POWERED UP TO A BLANK UPPER SCREEN. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT IMPACT 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