BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3151603 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00576
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 26, 2013
    Report Date
    March 28, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE RATE KNOB WAS UNABLE TO BE ADJUSTED, WHICH WAS ATTRIBUTED TO THE ENCODER FLEX BEING DAMAGED BY THE UNIT APPARENTLY HAVING BEEN DISASSEMBLED AND REASSEMBLED PRIOR TO ITS RETURN FOR SERVICING. ANALYSIS ALSO FOUND THAT THE UPPER AND LOWER CASES AND BOTH BAIL COVERS WERE BROKEN, THE BATTERY RELEASE AND LEAD FLEX COVER WERE CONTAMINATED, ONE CASE SCREW WAS MISSING, THE BATTERY CONTACTS WERE COMPRESSED, THE BATTERY DRAWER WAS DAMAGED, THE KEYBOARD WAS NOT SEATED PROPERLY, THE LIQUID CRYSTAL DISPLAY (LCD) WAS MISSING PIXELS, THE BATTERY FLEX WAS CORRODED AND THE SERIAL NUMBER LABEL WAS DAMAGED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RATE KNOB ON THE EXTERNAL PULSE GENERATOR WOULD NOT WORK, THAT IT WAS STUCK AT 80 BEATS PER MINUTE (BPM). THE GENERATOR WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RATE KNOB ON THE EXTERNAL PULSE GENERATOR WOULD NOT WORK, THAT IT WAS STUCK AT 80 BEATS PER MINUTE (BPM). THE GENERATOR WAS RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253107 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1