BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152532 · Received June 7, 2013

    Report

    Report Number
    2182208-2013-01543
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 19, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE ATRIAL LIGHT-EMITTING DIODE (LED) AND IT WAS ATTRIBUTED TO THE KEYBOARD BEING OUT OF SPECIFICATION ELECTRICALLY. (B)(4).

    Additional Manufacturer Narrative · 1

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

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL SENSE LIGHT-EMITTING-DIODE (LED) ON THE EXTERNAL PULSE GENERATOR WAS NOT WORKING. THE GENERATORWAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL SENSE LIGHT-EMITTING-DIODE (LED) ON THE EXTERNAL PULSE GENERATOR WAS NOT WORKING. THE GENERATOR WAS RETURNED FOR SERVICE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252076 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1