BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152313 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00688
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE DISPLAY LENS WAS BROKEN. IT WAS ALSO NOTED THAT THE UPPER CASE WAS BROKEN, THE LOWER CASE WAS BROKEN, TWO SIDE BAIL COVERS WERE BROKEN, THE BATTERY CONTACTS WERE COMPRESSED, TWO SIDE BAILS WERE BENT AND THE BATTERY DRAWER O-RING WAS MISSING.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) HAD A CRACKED SCREEN. THE BIOMEDICAL ENGINEER STATED THAT IT LOOKED LIKE THE EPG HAD BEEN DROPPED, BUT THIS COULD NOT BE CONFIRMED. IT WAS FURTHER NOTED THE EPG STILL FUNCTIONED. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253055 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1