BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2791499 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01596
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 10, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. HEART LEAD FLEX IS OUT OF SPECIFICATION (ONE DIODE ON THE VENTRICULAR SIDE HAS LOW RESISTANCE). UPPER CASE IS DENTED. LOWER CASE AND SIDE BAIL COVERS ARE BROKEN. BATTERY DRAWER IS OUT OF SPECIFICATION (LATCH IS DENTED). SIDE BAILS AND RING ARE MISSING. HEART WIRE CONTACTS ARE CONTAMINATED. SERIAL NUMBER LABEL IS TORN (COSMETIC). LCD (LIQUID CRYSTAL DISPLAY) GASKET IS OBSTRUCTING THE VIEW OF THE LCD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE DOING PREVENTIVE MAINTENANCE, THE EPG (EXTERNAL PULSE GENERATOR) WAS NOT READING ACCURATELY. THE ATRIAL AND VENTRICULAR SENSE LEDS (LIGHT EMITTING DIODES) WERE ALSO FLASHING. TROUBLESHOOTING DETERMINED THE ATRIAL CHANNEL WAS WORKING FINE, BUT THE VENTRICULAR CHANNEL WAS NOT OPERATING PROPERLY. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    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