BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2791395 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01595
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 9, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 CONFIRMED THE REPORTED EVENT, THE VENTRICULAR OUTPUT CONNECTOR WAS BROKEN AND THE DISPLAY WAS MISSING PIXELS. IT WAS ALSO NOTED THAT THE UPPER AND LOWER CASES WERE CONTAMINATED, THE RING COVER WAS CONTAMINATED, THE LEAD FLEX COVER WAS CONTAMINATED, THE BATTERY CONTACTS WERE COMPRESSED, THE RING WAS BENT, THE BATTERY DRAWER AND O-RING WERE CONTAMINATED AND THE KEYBOARD WAS SCRATCHED.

    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, THE VENTRICULAR OUTPUT CONNECTOR WAS BROKEN AND THE DISPLAY WAS MISSING PIXELS. IT WAS ALSO NOTED THAT THE UPPER AND LOWER CASES WERE CONTAMINATED, THE RING COVER WAS CONTAMINATED, THE LEAD FLEX COVER WAS CONTAMINATED, THE BATTERY CONTACTS WERE COMPRESSED, THE RING WAS BENT, THE BATTERY DRAWER AND O-RING WERE CONTAMINATED AND THE KEYBOARD WAS SCRATCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR OUTPUT CONNECTOR ON THE EXTERNAL PULSE GENERATOR WAS DAMAGED AND UNUSABLE. IT WAS FURTHER REPORTED THAT THERE WERE LINES IN THE LOWER LIQUID CRYSTAL DISPLAY (LCD). THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED ON THE RETURN PAPERWORK 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. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Other