BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3151575 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00501
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Report Date
    March 18, 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
    BIOMEDICAL ENGINEER

    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 COULD NOT CONFIRM THE REPORTED EVENT. IT WAS NOTED THAT THE BATTERY DRAWER WAS BROKEN, THE DISPLAY WAS OUT OF SPECIFICATION, WITH A GASKET SEEPING INTO THE DISPLAY, THE UPPER CASE WAS BROKEN, THE LOWER CASE WAS CONTAMINATED, THE RING COVER WAS BROKEN, TWO SIDE BAIL COVERS WERE CONTAMINATED, THE LEAD FLEX COVER WAS CONTAMINATED, THE BATTERY CONTACTS WERE COMPRESSED, THE RING WAS MISSING AND ONE SIDE BAIL WAS BENT, THE KEYBOARD PAD WAS CONTAMINATED AND COSMETICALLY DAMAGED, AND THE BATTERY RELEASE WAS CONTAMINATED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE "FRONT PLATEN" OF THE EXTERNAL PULSE GENERATOR (EPG) WAS CRACKED. THE EPG WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. FOLLOW-UP ATTEMPT WAS UNSUCCESSFUL IN OBTAINING ADDITIONAL INFORMATION ABOUT THE "FRONT PLATEN" BEING CRACKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252221 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1