BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2790736 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01587
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 8, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 COULD NOT CONFIRM THE REPORTED EVENT. UPPER AND LOWER CASE HALVES ARE BROKEN AND DAMAGED. BATTERY RELEASE IS CONTAMINATED. BOTH BAIL COVERS, RING COVER, AND BATTERY DRAWER ARE BROKEN. LEAD FLEX COVER IS CORRODED. BATTERY CONTACTS ARE COMPRESSED. THE RING IS BENT. SERIAL NUMBER LABEL IS TORN. BATTERY DRAWER O-RING IS MISSING. ONE PRINTED CIRCUIT BOARD FLEX IS CREASED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR WAS NOT ALWAYS SENSING APPROPRIATELY, THAT THE SETTINGS COULD NOT ALWAYS BE UNLOCKED AND THAT THE SETTINGS WERE NOT ABLE TO BE CHANGED. THE GENERATOR WAS RETURNED FOR SERVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF 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