BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3152138 · Received June 7, 2013

    Report

    Report Number
    2183613-2013-00520
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 7, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT; LCD (LIQUID CRYSTAL DISPLAY) OUT OF ELECTRICAL SPECIFICATION (SEGMENTS MISSING). ANALYSIS ALSO FOUND THE UPPER CASE, LOWER CASE, BATTERY RELEASE, RING COVER, TWO SIDE BAIL COVERS, BATTERY DRAWER, AND BATTERY DRAWER O-RING ARE CONTAMINATED. BATTERY CONTACTS ARE COMPRESSED AND THE RING IS BENT.

    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 LIQUID CRYSTAL DISPLAY (LCD) OF THE EXTERNAL PULSE GENERATOR HAD LINES IN IT. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253340 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1