BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3860028 · Received June 10, 2014

    Report

    Report Number
    2183613-2014-00807
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 23, 2014
    Report Date
    April 23, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: INITIAL ANALYSIS CONFIRMED THE REPORTED EVENT, THE VENTRICULAR CONNECTOR WAS BROKEN. IT WAS ALSO NOTED THAT THE UPPER CASE, SIDE BAIL COVERS AND RING COVER WERE BROKEN, THE RING BAIL WAS BENT, THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS OUT OF ELECTRICAL SPECIFICATION AND THE ENCODER FLEX WAS OUT OF SPECIFICATION WITH MECHANICAL TRACES SHIFTED. FURTHER ANALYSIS WAS PERFORMED ON THE MAIN PCB. VISUAL INSPECTION REVEALED NO ANOMALIES. BENCH ANALYSIS FOUND THAT SUPERCAPS FAILED IN-CIRCUIT, AND THE BATTERY REMOVAL TEST FAILED. ONCE BOTH CAPACITORS WERE REPLACED THE BATTERY REMOVAL TEST PASSED. CONCLUSION: CONFIRMED BATTERY REMOVAL FAILURE CAUSED BY A CAPACITOR COMPONENT FAILURE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE VENTRICAL OUTPUT SOCKET IS DAMAGED. THE DEVICE 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
    340207 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388X

    Patients

    Seq Age Sex Outcome Treatment
    1