BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3991774 · Received August 8, 2014

    Report

    Report Number
    2183613-2014-00973
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    April 25, 2014
    Report Date
    May 20, 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. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS FOUND THE LCD (LIQUID CRYSTAL DISPLAY) IS DAMAGED. ANALYSIS ALSO FOUND THE BATTERY CONTACTS ARE COMPRESSED. THE UPPER CASE, LOWER CASE, AND TWO SIDE BAIL COVERS ARE BROKEN. TWO CASE SCREWS AND TWO SIDE BAILS ARE MISSING. THE RING IS BENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS DROPPED AND BOTH SCREENS (TOP AND BOTTOM) ARE BROKEN. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR, ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468647 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1