BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3151817 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00560
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 28, 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
    KY, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE LIQUID CRYSTAL DISPLAY (LCD) WAS OUT OF SPECIFICATION, IT HAD SEGMENTS MISSING, SO IT WAS REPLACED. ANALYSIS ALSO FOUND TWO SIDE BAILS, THE RING, TWO SIDE BAIL COVERS AND THE RING COVER MISSING, THE UPPER AND LOWER CASES AND THE BATTERY DRAWER BROKEN, THE BATTERY RELEASE, LEAD FLEX COVER AND KEYBOARD PAD CONTAMINATED AND THE BATTERY CONTACTS COMPRESSED.

    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 DISPLAY OF THE EXTERNAL PULSE GENERATOR HAD MISSING SEGMENTS. IT WAS FURTHER REQUESTED THAT THE GENERATOR RECEIVE A NEW HANGER AND THAT AN EXTRA BATTERY DRAWER BE RETURNED WITH THE DEVICE. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THE ISSUE WAS DISCOVERED DURING A ROUTINE INSPECTION AND THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISPLAY OF THE EXTERNAL PULSE GENERATOR HAD MISSING SEGMENTS. IT WAS FURTHER REQUESTED THAT THE GENERATOR RECEIVED A NEW HANGER AND THAT AN EXTRA BATTERY DRAWER BE RETURNED WITH THE DEVICE. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THE ISSUE WAS DISCOVERED DURING A ROUTINE INSPECTION AND THAT THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253242 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1