BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2791428 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01716
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    July 10, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. EVALUATION SUMMARY: (B)(4) ANALYSIS CONFIRMED THE REPORTED EVENT. KEYBOARD IS OUT OF SPECIFICATION (SELECT KEY IS DAMAGED, INTERMITTENT). UPPER AND LOWER CASES AND SIDE BAIL COVERS ARE BROKEN. RING COVER IS CONTAMINATED. BATTERY CONTACTS ARE COMPRESSED. SERIAL NUMBER LABEL IS TORN. RING BAIL IS BENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR FAILED ITS SELF-TEST AND DISPLAYED AN ERROR CODE INDICATING A DAMAGED "SELECT" BUTTON. THE CALLER DID INDICATE THAT "THE USERS HAVE SMASHED THE SELECT BUTTON." THE PROGRAMMER WAS RETURNED FOR SERVICE. IT WAS INDICATED ON THE RETURN PAPERWORK THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other