BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2791556 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01730
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    July 17, 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

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): BATTERY CONTACTS ARE COMPRESSED. BATTERY DRAWER IS CONTAMINATED. UPPER AND LOWER CASE HALVES AND BOTH BAIL COVERS ARE BROKEN. KEYBOARD WINDOW IS SCRATCHED.

    Description of Event or Problem · 1

    THE EXTERNAL PULSE GENERATOR WAS RETURNED TO THE MANUFACTURER FOR REPAIR, ANALYZED AND TESTED OUT OF SPECIFICATION. THE UNIT WAS FOUND IN THE BIOMEDICAL DEPARTMENT OF THE HOSPITAL AND NO PATIENT INVOLVEMENT WAS INDICATED.

    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