BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASKU

    MDR report key: 1803001 · Received August 17, 2010

    Report

    Report Number
    2182208-2010-00577
    Event Type
    Malfunction
    Date Received
    August 17, 2010
    Date of Event
    June 7, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P820003/S70
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. NOTE: THERE ARE 3 CABLES WITH MODEL 5433A AND 1 CABLE WITH MODEL 5433V; ALL REPRESENTED UNDER THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 RECENT FAILURES OF THE TEMPORARY EXTERNAL PULSE GENERATOR (EPG) CABLES WAS FOUND. THE REPORTER WAS UNSURE OF THE LENGTH OF SERVICE OF THE LEADS, BUT FOUND IT CONCERNING THAT 4 FAILED AT ONCE. IT WAS NOTED THAT A COUPLE OF THEM LOOKED OLD, BUT THE NEWER ONES HAD CONNECTOR DAMAGE (ONE HAS BEEN STICKY TAPED). THE BLACK CONNECTOR SNAPPED OFF. A PART IS MISSING FROM THE BLACK CONNECTOR. A PART WAS MISSING FROM BLADE CONNECTOR. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. NOTE: THERE ARE A TOTAL OF 4 CABLES REPRESENTED UNDER THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASKU INSTRUMENT CABLE DTB MEDTRONIC, INC. 5433A ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other