BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3153590 · Received June 8, 2013

    Report

    Report Number
    2183613-2013-00615
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 5, 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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE CUSTOMER COMMENT OF "LOW BATTERY", THE RETURNED BATTERY MEASURED NEAR THE "LOW BATTERY INDICATION" MARK, HOWEVER ANALYSIS COULD NOT CONFIRM CUSTOMER COMMENT OF THE GENERATOR BEING BROKEN. THE BATTERY WAS REPLACED AND THE GENERATOR PASSED ALL FINAL QUALITY ASSURANCE TESTS. (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 EXERNAL PULSE GENERATOR WAS "BROKEN", THAT IT HAD A LOW BATTERY. IT WAS FURTHER REQUESTED THAT IT HAVE ITS ANNUAL TEST AND CALIBRATION. THE GENERATOR WAS RETURNED FOR SERVICE. NO INDICATION WAS GIVEN AS TO PATIENT INVOLVEMENT, NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR WAS "BROKEN", THAT IT HAD A LOW BATTERY. IT WAS FURTHER REQUESTED THAT IT HAVE ITS ANNUAL TEST AND CALIBRATION. THE GENERATOR WAS RETURNED FOR SERVICE. NO INDICATION WAS GIVEN AS TO PATIENT INVOLVEMENT, NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257400 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1