BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2791169 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01695
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    July 5, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S70
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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): ANALYSIS CONFIRMED THE REPORTED EVENT. INTERCONNECT FLEX IS OUT OF ELECTRICAL SPECIFICATION. DEVICE SENSITIVITY IS OUT OF SPECIFICATION. FLEXES ON THE INTERCONNECT FLEX AND CONNECTOR OF THE MAIN PRINTED CIRCUIT BOARD ASSEMBLY ARE SLIGHTLY MISALIGNED. LOWER CASE IS BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE BIOMED TESTED THE DEVICE, THE VENTRICULAR SENSITIVITY WAS FOUND WAY OUT OF SPECIFICATION. THE BIOMED RETESTED THE DEVICE USING THE RECOMMENDED WAVEFORM AND THE VENTRICULAR SENSITIVITY PASSED. THE DEVICE WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTERNAL PULSE GENERATOR DTE MEDTRONIC MILACA INC. 5348

    Patients

    Seq Age Sex Outcome Treatment
    1 Other