BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2790106 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01649
    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
    NJ, 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 THE UPPER CASE AND LOWER CASE WERE CORRODED AND CONTAMINATED, THE SIDE BAIL COVERS AND SIDE BAILS WERE MISSING, THE RING COVER, HEART BLOCK AND KEYBOARD WERE CONTAMINATED, THE LEAD FLEX COVER, TWO PRINTED CIRCUIT BOARD (PCB) SCREWS, MAIN PCB, BATTERY FLEX AND HEART LEAD FLEX WERE CORRODED, THE RING WAS BENT, THE BATTERY DRAWER WAS BROKEN, THE DISPLAY WAS OUT OF SPECIFICATION AND THE DISPLAY WAS CORRODED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE EXTERNAL PULSE GENERATOR (EPG) WAS RETURNED FOR REPAIR. FOLLOW-UP ATTEMPTS TO OBTAIN DETAILS OF THE REPAIR REQUEST WERE UNSUCCESSFUL. THE DEVICE WAS ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT.

    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