BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3860418 · Received June 10, 2014

    Report

    Report Number
    2183613-2014-00776
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    January 22, 2014
    Report Date
    March 5, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE UPPER AND LOWER CASES WERE BROKEN. HOWEVER IT WAS ALSO NOTED THAT THE BATTERY RELEASE WAS CONTAMINATED, BOTH BAIL COVERS WERE BROKEN, THE RING COVER WAS CONTAMINATED, ONE CASE SCREW WAS MISSING, THE LEAD FLEX COVER WAS CONTAMINATED, THE BATTERY CONTACTS WERE COMPRESSED, THE RING WAS BENT, THE BATTERY DRAWER AND O-RING WERE CONTAMINATED, THE KEYBOARD WAS SCRATCHED, THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS OUT OF ELECTRICAL SPECIFICATION AND THE HEART LEAD FLEX WAS OUT OF SPECIFICATION. FURTHER ANALYSIS WAS PERFORMED ON THE MAIN PCB AND THE HEART LEAD FLEX. VISUAL INSPECTION REVEALED THAT THE TAIL THICKNESS WAS WITHIN SPECIFICATION ON THE FLEX, NO ANOMALIES OBSERVED ON THE MAIN PCB. BENCH ANALYSIS FOUND THAT A DIODE FAILED IN-CIRCUIT TESTING ON THE LEAD FLEX, AND ONE CAPACITOR IN-CIRCUIT FAILED, TYPICAL OPERATION WAS OBSERVED WHEN THE DEVICE WAS TURNED ON, BATTERY REMOVAL TEST FAILED, ONCE THE CAPACITOR WAS REPLACED THE BATTERY REMOVAL TEST PASSED. CONCLUSION: CONFIRMED DEFECTIVE LEAD FLEX CAUSED BY A DIODE COMPONENT FAILURE, CONFIRMED THE DEFECTIVE MAIN PCB CAUSED BY A CAPACITOR COMPONENT FAILURE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR HAD A CRACK IN ITS CASE AND WAS DUE FOR ITS ANNUAL PREVENTIVE MAINTENANCE. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343259 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1