BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3991103 · Received August 8, 2014

    Report

    Report Number
    2183613-2014-00999
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    April 28, 2014
    Report Date
    June 4, 2014
    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 LOWER CASE WAS BROKEN. IT WAS ALSO NOTED THAT THE UPPER CASE WAS BROKEN, BOTH BAIL COVERS WERE MISSING, THE RING COVER WAS BROKEN, THE BATTERY CONTACTS WERE COMPRESSED, THE RING AND BOTH BAILS WERE MISSING, THE BATTERY DRAWER WAS BROKEN AND THE KEYBOARD WAS SCRATCHED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CASE IS DAMAGED. THE DEVICE WAS RETURNED FOR REPAIR. IT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471823 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1