BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2790918 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01611
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 17, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S70
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. MAIN KEYBOARD PAD IS OUT OF SPECIFICATION (COLLAPSED BUTTONS). UPPER CASE IS BROKEN AND LOWER CASE IS BROKEN/CONTAMINATED. BATTERY DRAWER IS OUT OF SPECIFICATION (WORN). RING COVER, TWO SIDE BAIL COVERS, AND HIGH RATE COVER ARE CONTAMINATED. BATTERY CONTACTS ARE COMPRESSED. THE RING IS BENT.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE BIOMEDICAL ENGINEER THAT THE KEYPAD OF THE EPG (EXTERNAL PULSE GENERATOR) IS WORN OUT, AND IT IS DIFFICULT TO TURN THE EPG ON/OFF WHEN PRESSING THE BUTTONS. THERE WAS NO PATIENT INVOLVEMENT. IT WAS LATER REPORTED THAT THE EPG WOULD NOT POWER ON/OFF. IT TURNED OFF, THEN ON, AND WOULD NOT SHUT OFF. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE EPG WAS RETURNED FOR REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTERNAL PULSE GENERATOR DTE MEDTRONIC MILACA INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1 Other