BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 2953635 · Received February 9, 2013

    Report

    Report Number
    2183613-2013-00189
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Report Date
    December 20, 2012
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 CONFIRMED THE REPORTED EVENT, DEVICE HAD PHYSICAL DAMAGE. IT WAS NOTED THAT THE UPPER AND LOWER CASES WERE BROKEN, THE RING COVER AND TWO SIDE BAIL COVERS WERE BROKEN, THE BATTERY RELEASE AND KEYBOARD PAD WERE CONTAMINATED, THE LEAD FLEX COVER AND BATTERY DRAWER WERE BROKEN, ONE CASE SCREW WAS MISSING, THE BATTERY CONTACTS WERE COMPRESSED, THE RING AND TWO SIDE BAILS WERE MISSING, THE DISPLAY WAS OUT OF SPECIFICATION, AND THE BATTERY DRAWER O-RING WAS MISSING. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR HAD PHYSICAL DAMAGE. THE GENERATOR WAS RETURNED FOR SERVICE. IT WAS ANALYZED AND TESTED OUT OF SPECIFICATION. IT WAS INDICATED THAT THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56931 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1