BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3990251 · Received August 7, 2014

    Report

    Report Number
    2183613-2014-01042
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    May 5, 2014
    Report Date
    June 4, 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
    NY, US
    Reporter Occupation
    OTHER

    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 FOUND THE UPPER CASE IS DENTED AND BROKEN AND LOWER CASE IS BROKEN. ANALYSIS ALSO FOUND THE BATTERY RELEASE AND BATTERY DRAWER ARE CONTAMINATED. RING COVER AND SIDE BAIL COVERS ARE BROKEN. BATTERY CONTACTS ARE COMPRESSED, RING BAIL IS MISSING, AND KEYBOARD IS DELAMINATING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE CASE IS DAMAGED. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR REPAIR, ANALYZED AND TESTED OUT OF SPECIFICATION. THERE WAS NO PATIENT INVOLVEMENT INDICATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464219 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1