BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2791240 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01579
    Event Type
    Injury
    Date Received
    October 15, 2012
    Date of Event
    August 2, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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. UPPER CASE AND BOTH BAIL COVERS ARE BROKEN. RING COVER IS CONTAMINATED. BATTERY CONTACTS ARE COMPRESSED. THE RING IS BENT. LCD (LIQUID CRYSTAL DISPLAY) IS MISSING THE RIGHT HAND COLUMNS ON THE LOWER PART OF THE DISPLAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR WAS NOT MEASURING THE PACING RATE PROPERLY. THE GENERATOR WAS CHANGED OUT AND RETURNED FOR SERVICE. 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 MILACA INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention