BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3990941 · Received August 8, 2014

    Report

    Report Number
    2183613-2014-01013
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 22, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Removal / Correction Number
    Z-0430-2011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS DEVICE WAS INCLUDED IN THAT FIELD ACTION, BUT RETURNED PRODUCT TESTING FOUND THE DEVICE DID NOT PERFORM AS DESCRIBED IN THE FIELD ACTION. PRODUCT EVENT SUMMARY: ANALYSIS CONFIRMED THE REPORTED EVENT; UPPER AND LOWER CASES ARE BROKEN AND LCD (LIQUID CRYSTAL DISPLAY) IS OUT OF SPECIFICATION (MISSING PIXELS). ANALYSIS ALSO FOUND ONE BAIL COVER IS BROKEN. TWO CASE SCREWS AND BOTH BAILS ARE MISSING. BATTERY CONTACTS ARE COMPRESSED, BATTERY DRAWER HAS PRY MARKS, AND KEYBOARD IS SCRATCHED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE WAS DROPPED AND THE CASE AND THE LOWER DISPLAY ARE BROKEN. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR, ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470422 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1