BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3153281 · Received June 8, 2013

    Report

    Report Number
    2183613-2013-00604
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 21, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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: ANALYSIS CONFIRMED THE REPORTED EVENT, THE VENTRICULAR OUTPUT CONNECTOR WAS BROKEN, AS A RESULT THE CONNECTOR WAS REPLACED. IT WAS ALSO NOTED THAT THE UPPER CASE WAS BROKEN, THE LOWER CASE WAS BROKEN, THE BATTERY RELEASE WAS CONTAMINATED, TWO SIDE BAIL COVERS WERE MISSING, THE RING COVER WAS MISSING, THE LEAD FLEX COVER WAS CONTAMINATED, TWO CASE SCREWS WERE MISSING, THE RING COVER SCREW WAS MISSING, THE BATTERY CONTACTS WERE COMPRESSED, THE BATTERY DRAWER WAS BROKEN, THE KEYBOARD PAD WAS COSMETICALLY DAMAGED (DELAMINATED), AND THE ENCODER FLEX WAS OUT OF SPECIFICATION (TORN FLEX).

    Description of Event or Problem · 1

    IT WAS REPORTED THE VENTRICULAR INPUT OF THE EPG (EXTERNAL PULSE GENERATOR) WAS BROKEN. THE EPG 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
    256100 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388X

    Patients

    Seq Age Sex Outcome Treatment
    1