BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3860185 · Received June 10, 2014

    Report

    Report Number
    2183613-2014-00791
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 25, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT; DEVICE PASSED ALL INCOMING FUNCTIONAL TESTS. ANALYSIS FOUND THE UPPER CASE, LOWER CASE, AND BATTERY DRAWER ARE BROKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE SHUTS OFF. THE BIOMED COULD NOT REPEAT THE PROBLEM. FOLLOWUP WITH THE BIOMED INDICATES THE DEVICE WAS CONNECTED TO A PATIENT AT THE TIME OF THE EVENT. THE DEVICE WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338740 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention