BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3160352 · Received June 10, 2013

    Report

    Report Number
    2183613-2013-00785
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Report Date
    April 29, 2013
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: ANALYSIS FOUND THAT THE DEVICE HAD FLUID INGRESSION, REPORTED EVENT CONFIRMED. IT WAS ALSO NOTED THAT THE UPPER CASE WAS BROKEN/CONTAMINATED, THE LOWER CASE WAS BROKEN/CONTAMINATED, THE BATTERY RELEASE WAS CONTAMINATED, TWO SIDE BAIL COVERS WERE CONTAMINATED, THE RING COVER WAS CONTAMINATED, THE LEAD FLEX COVER WAS CONTAMINATED, THE BATTERY CONTACTS WERE COMPRESSED, THE RING WAS BENT, THE BATTERY DRAWER WAS CONTAMINATED, THE DISPLAY WAS CONTAMINATED, THE MAIN PRINTED CIRCUIT BOARD (PCB) WAS CONTAMINATED, AND THE HEART LEAD FLEX WAS CONTAMINATED. (B)(4).

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER AFTER THE UNIT WAS DAMAGED BY WATER. IT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261091 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1