BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2951514 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00022
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT, THE LOWER DISPLAY WOULD NOT COME UP WHEN THE MENU BUTTON WAS PRESSED DUE TO THE DISPLAY WAS OUT OF SPECIFICATION. IT WAS ALSO NOTED THAT THE BATTERY DRAWER WAS HARD TO OPEN DUE TO THE LOWER CASE AND BATTERY RELEASE WERE CONTAMINATED, THE SIDE BAIL COVER AND HEART LEAD FLEX WERE BROKEN, THE RING WAS BENT, THE BATTERY DRAWER AND BATTERY FLEX WERE CONTAMINATED AND THE KEYBOARD WAS SCRATCHED. (B)(4).

    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 ON THE EXTERNAL PULSE GENERATOR THE LOWER DISPLAY WOULD NOT COME UP WHEN THE MENU BUTTON WAS PRESSED AND THAT THE BATTERY DOOR WAS VERY HARD TO OPEN. THE GENERATOR WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT, THIS WAS DISCOVERED DURING AN INSPECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE TESTING OF THE EXTERNAL PULSE GENERATOR (EPG), THE BIOMEDICAL ENGINEER FOUND THAT THE LOWER DISPLAY SCREEN WOULD NOT COME ON WHEN THE MENU BUTTON WAS PRESSED. THEREFORE, THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55466 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1