BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL PULSE GENERATOR

    MDR report key: 2791636 · Received October 15, 2012

    Report

    Report Number
    2183613-2012-01738
    Event Type
    Malfunction
    Date Received
    October 15, 2012
    Date of Event
    July 10, 2012
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    DTE
    PMA / PMN Number
    P820003/S72
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 CONFIRMED THE REPORTED EVENT. ONE DIODE ON THE VENTRICULAR SIDE OF THE HEART LEAD FLEX IS SHORTED. SIDE BAIL COVERS ARE BROKEN. THE RING IS BENT. KEYBOARD HAS A COSMETIC ISSUE. ENCODER FLEX IS OUT OF SPECIFICATION; ATRIAL OUTPUT CONTROL KNOB IS INTERMITTENTLY WORKING (SKIPPING NUMBER).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO OUTPUT ON THE VENTRICULAR SIDE OF THE EXTERNAL PULSE GENERATOR. THE GENERATOR WAS RETURNED FOR SERVICE. THIS WAS FOUND DURING ROUTINE TESTING AND 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