BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2790511 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01568
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 1, 2012
    Report Date
    August 1, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003/S72
    Removal / Correction Number
    Z-0430-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION. FURTHER ANALYSIS WAS PERFORMED ON THE MAIN PRINTED CIRCUIT BOARD. THIS ANALYSIS CONFIRMED THE REPORTED EVENT AND FAILURES FOUND DURING SERVICING OF THE DEVICE CAUSED BY FOREIGN MATERIAL CREATING INTERMITTENT SHORT ON DATA BUS CONNECTOR PINS.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE MAIN PRINTED CIRCUIT BOARD WAS OUT OF SPECIFICATION. IT WAS ALSO NOTED THAT THE BATTERY CONTACTS WERE COMPRESSED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE EPG (EXTERNAL PULSE GENERATOR) LOCKED UP. THE UPPER DISPLAY IS BLANK OR HAS LINES RUNNING THROUGH THE DISPLAY. OUTPUT IS CONSTANT AND CAN NOT BE ADJUSTED. IT WAS ALSO REPORTED THERE ARE DASHES IN THE LCD (LIQUID CRYSTAL DISPLAY) AND ODD CHARACTERS AND THE EPG WILL NOT TURN OFF. THE EPG IS BEING RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE EPG (EXTERNAL PULSE GENERATOR) LOCKED UP. THE UPPER DISPLAY IS BLANK OR HAS LINES RUNNING THROUGH IT. OUTPUT IS CONSTANT AND CANNOT BE ADJUSTED. IT WAS ALSO REPORTED THERE ARE DASHES IN THE LCD (LIQUID CRYSTAL DISPLAY) AND ODD CHARACTERS, AND THE EPG WILL NOT TURN OFF. THE EPG WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Other