BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2811089 · Received October 31, 2012

    Report

    Report Number
    2183613-2012-02038
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 4, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S70
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    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 CONFIRMED THE REPORTED EVENT. HIGH RATE LED (LIGHT EMITTING DIODE) DISPLAY SEGMENT MISSING. LOWER CASE IS BROKEN. OUTPUT CONNECTOR IS CONTAMINATED. HIGH RATE COVER HAS A COSMETIC ISSUE. DISCLAIMER: SUBMISSION OF INFORMATION BY MEDTRONIC UNDER THE MEDICAL DEVICE REPORTING REGULATION DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE (S) HAS MALFUNCTIONED OR THAT THERE IS ANY CAUSAL CONNECTION BETWEEN THE PERFORMANCE OF THE DEVICE AND ANY INJURY THAT MAY HAVE OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON THE EXTERNAL PULSE GENERATOR'S RAPID ATRIAL PACING DISPLAY, ONE SECTION DID NOT DISPLAY. FOR EXAMPLE, IF SET TO 320 THE DISPLAY WOULD SHOW 32. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTERNAL PULSE GENERATOR DTE MEDTRONIC MILACA INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1 Other