BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2791522 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01726
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): ANALYSIS FOUND THAT THERE WAS DUST ON THE DISPLAY LENS, THE KEYBOARD WAS SCRATCHED, THE CONNECTOR OF THE DISPLAY AND THE RING COVER WERE BROKEN, THE ENCODER FLEX WAS OUT OF SPECIFICATION, PINS OF THE CONNECTOR WERE BARELY MAKING CONTACT WITH ELECTRICAL TRACES ON THE FLEX, AND THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS OUT OF SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): ANALYSIS FOUND THAT THERE WAS DUST ON THE DISPLAY LENS, THE KEYBOARD WAS SCRATCHED, THE CONNECTOR OF THE DISPLAY AND THE RING COVER WERE BROKEN, THE ENCODER FLEX WAS OUT OF SPECIFICATION, PINS OF THE CONNECTOR WERE BARELY MAKING CONTACT WITH ELECTRICAL TRACES ON THE FLEX, AND THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS OUT OF SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR WAS RETURNED FOR REPAIR. PER FOLLOW UP, NO ADDITIONAL INFORMATION IS AVAILABLE. THE UNIT WAS FOUND IN THE BIOMEDICAL DEPARTMENT OF THE HOSPITAL AND NO PATIENT INVOLVEMENT WAS INDICATED. THE DEVICE WAS ANALYZED AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION.

    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