BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TBD

    MDR report key: 2812802 · Received October 31, 2012

    Report

    Report Number
    2183613-2012-01904
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 17, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE 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. (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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY EVALUATION SUMMARY (B)(4): THE GENERATOR WAS RETURNED AND ANALYSIS WAS UNABLE TO CONFIRM THE CUSTOMER COMMENT THAT THE LOWER DISPLAY WOULD NOT ALWAYS COME UP OR THAT IF IT DID IT WOULD NOT ALWAYS STAY UP. ANALYSIS DID FIND THAT THE LOWER CASE AND BOTH BAIL COVERS WERE BROKEN, THE BATTERY CONTACTS WERE COMPRESSED AND THE KEYBOARD WAS OUT OF SPECIFICATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE BIOMEDICAL ENGINEER THAT DURING A ROUTINE CHECK OF THE EXTERNAL PULSE GENERATOR (EPG), THE LOWER DISPLAY DID NOT ALWAYS COME UP OR THAT IT WOULD COME UP, BUT THEN GO AWAY. THE EPG WAS RETURNED FOR REPAIR. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE BIOMEDICAL ENGINEER THAT DURING A ROUTINE CHECK OF THE EXTERNAL PULSE GENERATOR (EPG), THE LOWER DISPLAY DID NOT ALWAYS COME UP OR THAT IT WOULD COME UP, BUT THEN GO AWAY. THE EPG WAS RETURNED FOR REPAIR. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE BIOMEDICAL ENGINEER THAT DURING A ROUTINE CHECK OF THE EXTERNAL PULSE GENERATOR (EPG), THE LOWER DISPLAY DID NOT ALWAYS COME UP OR THAT IT WOULD COME UP, BUT THEN GO AWAY. THE EPG WAS RETURNED FOR REPAIR. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other