BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, PACEMAKER, EXTERNAL

    MDR report key: 2965207 · Received February 15, 2013

    Report

    Report Number
    2183613-2013-00014
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY (B)(4): THE GENERATOR WAS RETURNED AND ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE DISPLAY LENS WAS CRACKED. ANALYSIS ALSO FOUND THAT THE UPPER AND LOWER CASES ARE BROKEN, ONE BAIL COVER WAS BROKEN, THE BATTERY CONTACTS WERE COMPRESSED, THE KEYBOARD WAS DAMAGED, THE LIQUID CRYSTAL DISPLAY (LCD) WAS OUT OF SPECIFICATION AND THE SERIAL NUMBER LABEL WAS DAMAGED. (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 THE DISPLAY ON THE EXTERNAL PULSE GENERATOR (EPG) WAS CRACKED. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DISPLAY ON THE EXTERNAL PULSE GENERATOR (EPG) WAS CRACKED. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69153 PULSE-GENERATOR, PACEMAKER, EXTERNAL DTE MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1