BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3151552 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00505
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 4, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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

    EVALUATION SUMMARY: THE GENERATOR WAS RETURNED AND ANALYSIS WAS UNABLE TO CONFIRM THE CUSTOMER COMMENT THAT THE DEVICE DID NOT OPERATE CORRECTLY, THAT SPANISH APPEARED ON THE SCREEN, THAT THE BOTTOM MENU WOULD NOT COME UP NOR THAT THE RATE CAME UP AT ZERO AND WAS NOT ABLE TO BE ADJUSTED. ANALYSIS DID FIND THAT BOTH BAIL COVERS AND THE BATTERY DRAWER WERE BROKEN, THE BATTERY CONTACTS WERE COMPRESSED, THE BATTERY DRAWER O-RING WAS MISSING AND THAT THE KEYBOARD WINDOW WAS SCRATCHED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE DOES NOT OPERATE CORRECTLY. AFTER POST (POWER ON SELF TEST) THERE IS SPANISH ON SCREEN, BOTTOM MENU WON'T COME UP, AND RATE COMES UP ZERO AND WON'T ADJUST. THE DEVICE WAS RETURNED FOR REPAIR AND CALIBRATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE DOES NOT OPERATE CORRECTLY. AFTER POST (POWER ON SELF TEST) THERE IS SPANISH ON SCREEN, BOTTOM MENU WON'T COME UP, AND RATE COMES UP ZERO AND WON'T ADJUST. THE DEVICE WAS RETURNED FOR REPAIR AND CALIBRATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252791 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1