BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3859979 · Received June 10, 2014

    Report

    Report Number
    2183613-2014-00810
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 21, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT, THE DEVICE PASSED FUNCTIONAL AND BENCH TESTING WITH NO ANOMALIES FOUND. IT WAS NOTED THAT THE UPPER CASE WAS BROKEN, THE LOWER CASE WAS BROKEN, THE BATTERY RELEASE WAS CONTAMINATED, TWO SIDE BAIL COVERS WERE BROKEN, THE RING COVER WAS BROKEN, THE LEAD FLEX COVER WAS BROKEN, THE BATTERY CONTACTS WERE COMPRESSED, TWO SIDE BAILS WERE BENT/MISSING, THE RING WAS MISSING, AND THE BATTERY DRAWER WAS BROKEN AND CONTAMINATED.

    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 EPG (EXTERNAL PULSE GENERATOR) FIRED ON THE T-WAVE, INSTEAD OF THE Q OR R-WAVE, WHILE IN USE ON A PATIENT. THE EPG WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340116 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R