BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152974 · Received June 8, 2013

    Report

    Report Number
    2183613-2013-00589
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 3, 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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE CUSTOMER COMMENT THAT THE OFF-BUTTON ON THE KEYBOARD PAD WAS OUT OF SPECIFICATION. ANALYSIS ALSO FOUND THE UPPER CASE BROKEN, THE LOWER CASE, BATTERY RELEASE, LEAD FLEX COVER AND BATTERY DRAWER CONTAMINATED, THE TWO SIDE BAIL COVERS BROKEN AND CONTAMINATED, THE BATTERY CONTACTS COMPRESSED AND THE LIQUID CRYSTAL DISPLAY (LCD) OUT OF SPECIFICATION (SEGMENTS MISSING). (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 EXTERNAL PULSE GENERATOR (EPG) WOULD NOT ALWAYS POWER OFF. THE BIOMEDICAL ENGINEER HAS TO PRESS THE OFF BUTTON HARD AND SEVERAL TIMES BEFORE THE DEVICE WOULD SHUT OFF. THEREFORE, THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) WOULD NOT ALWAYS POWER OFF. THE BIOMEDICAL ENGINEER HAS TO PRESS THE OFF BUTTON HARD AND SEVERAL TIMES BEFORE THE DEVICE WOULD SHUT OFF. THEREFORE, THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256130 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention