BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2790937 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01574
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    August 1, 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
    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, THE DEVICE PASSED ALL FUNCTIONAL TESTING. IT WAS NOTED THAT THE KEYBOARD WAS SCRATCHED AND THE OFF KEY WAS COLLAPSED, THE UPPER CASE, SIDE BAIL COVERS, RING COVER AND BATTERY DRAWER WERE CONTAMINATED, THE LOWER CASE WAS BROKEN, THE BATTERY CONTACTS WERE COMPRESSED AND THE RING BAIL WAS BENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR DID NOT TURN ON. DIFFERENT NEW BATTERY BATCHES WERE USED AND IT WOULD NOT POWER ON. IT WAS ALSO STATED AS "THE 'ON' KEY MUST BE PRESSED SEVERAL TIMES BEFORE THE UNIT POWERED ON, AND THAT WAS INTERMITTENT AS WELL." THE GENERATOR WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH 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