BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152494 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00666
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    MEDTRONIC MILACA INC
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE 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 BATTERY DRAWER WAS BROKEN AND IT WAS REPLACED. ANALYSIS ALSO FOUND THAT THE HIGH RATE COVER, TWO BATTERY LATCHES AND THE HEART FLEX LEAD WERE CONTAMINATED, THAT THE UPPER CASE, LOWER CASE, THREE CONTROL KNOBS, TWO SIDE BAIL COVERS AND THE RING COVER WERE BROKEN AND ONE BATTERY RELEASE SPRING AND THE RING WERE BENT. (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 BATTERY DRAWER ON THE EXTERNAL PULSE GENERATOR WAS HARD TO CLOSE. IT WAS FURTHER REQUESTED THAT THE GENERATOR RECEIVE A CALIBRATION. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY DRAWER ON THE EXTERNAL PULSE GENERATOR WAS HARD TO CLOSE. IT WAS FURTHER REQUESTED THAT THE GENERATOR RECEIVE A CALIBRATION. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253124 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA INC 5348

    Patients

    Seq Age Sex Outcome Treatment
    1