BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3151951 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00542
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 5, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT; LCD (LIQUID CRYSTAL DISPLAY) IS OUT OF ELECTRICAL SPECIFICATION (MISSING PIXELS, LOWER SCREEN). ANALYSIS ALSO FOUND THE UPPER CASE, LOWER CASE, AND ONE BAIL COVER ARE BROKEN. LCD LENS IS CRACKED. BATTERY RELEASE AND LEAD FLEX COVER ARE CONTAMINATED. ONE BAIL COVER, RING COVER, ONE BAIL, RING, AND BATTERY DRAWER O-RING ARE MISSING. BATTERY CONTACTS ARE COMPRESSED. ONE BAIL IS BENT AND THE KEYBOARD IS SCRATCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE EPG (EXTERNAL PULSE GENERATOR) SCREEN WAS DISTORTED AT THE BOTTOM WHEN TURNED ON. THE EPG WAS RETURNED FOR REPAIR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252652 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1