BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3991282 · Received August 8, 2014

    Report

    Report Number
    2183613-2014-00996
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY: INITIAL ANALYSIS CONFIRMED THE REPORTED EVENT, THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS OUT OF ELECTRICAL SPECIFICATION. IT WAS ALSO NOTED THAT THE UPPER AND LOWER CASES WERE BROKEN, THE RING COVER AND BOTH BAIL COVERS WERE MISSING, FOUR CASE SCREWS WERE MISSING, THE BATTERY CONTACTS WERE COMPRESSED, THE RING AND BOTH BAILS WERE MISSING, THE BATTERY DRAWER WAS BROKEN, THE KEYBOARD WAS OUT OF SPECIFICATION WITH THE OFF BUTTON BEING COLLAPSED AND THE KEYBOARD WAS SCRATCHED. FURTHER ANALYSIS WAS PERFORMED ON THE MAIN PCB. VISUAL INSPECTION REVEALED NO ANOMALIES. BENCH ANALYSIS REVEALED A FAILURE FOR POWER SUPPLY CURRENT LIMIT, AFTER REPLACING AN INTEGRATED CIRCUIT COMPONENT, TYPICAL OPERATION WAS OBSERVED AT POWER UP. FULL FUNCTIONAL TEST WAS THEN PERFORMED, NO ANOMALIES WERE FOUND. CONCLUSION: CONFIRMED THE POWER UP FAILURE CAUSED BY INTEGRATED CIRCUIT COMPONENT FAILURE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE EXTERNAL PULSE GENERATOR WAS TURNED ON THE DISPLAY WAS BLANK. THE GENERATOR WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468609 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1