BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3151754 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00564
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 1, 2013
    Manufacturer
    MEDTRONIC MILACA INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. DEVICE PASSED FUNCTIONAL TESTING. IT WAS NOTED THAT THE UPPER CASE WAS BROKEN AND THE RING COVER WAS BROKEN.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (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 EXTERNAL PULSE GENERATOR TURNED ITSELF OFF WHILE PACING A PATIENT WITH NO PREVIOUS WARNING OR INDICATOR LIGHT. THE PATIENT WENT INTO A VENTRICULAR "STAND STILL." THE GENERATOR WAS RETURNED FOR SERVICE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252687 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1