BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3153657 · Received June 8, 2013

    Report

    Report Number
    2183613-2013-00618
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Report Date
    March 13, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. IT WAS ALSO NOTED THAT THE BATTERY RELEASE AND LEAD FLEX COVER WERE CONTAMINATED AND CORRODED, BAIL COVERS AND RING COVER WERE MISSING, THE BATTERY CONTACTS WERE COMPRESSED AND CONTAMINATED, THE BAILS AND RING WERE MISSING, THE BATTERY DRAWER WAS BROKEN, THE BATTERY FLEX WAS CONTAMINATED AND CORRODED, THE HEART LEAD FLEX WAS OUT OF SPECIFICATION, AND THE DISPLAY WAS CONTAMINATED. FURTHER ANALYSIS WAS PERFORMED ON THE HEART LEAD FLEX. THIS ANALYSIS FOUND THAT THE FLEX ASSEMBLY FAILED TESTING DUE A DIODE COMPONENT BEING OUT OF SPECIFICATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR HAD EXTENSIVE CASE DAMAGE AND MAY HAVE BEEN DROPPED. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256451 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1