BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW-IN

    MDR report key: 2952414 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00566
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    October 29, 2012
    Report Date
    November 5, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    K902002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (B)(6) 2008. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE DEVICE CHANGE OUT, WHEN THE LEFT VENTRICULAR LEAD WAS REATTACHED TO THE NEW DEVICE IT WAS EVIDENT THAT THE LEAD WAS NOT WORKING. THE LEAD HAD IMPEDANCE > 3000 OHMS, NO CAPTURE, AND THE PHYSICIAN MENTIONED THAT THE CONNECTOR LOOKED BROKEN PRIOR TO CONNECTING IT TO THE NEW DEVICE. THE LEAD REMAINS IN PLACE BUT NOT IN USE. THE NEW DEVICE WAS REPROGRAMMED TO PACE IN THE RIGHT VENTRICLE ONLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56367 SCREW-IN ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5071-35

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention 6947 IMPLANTABLE TACHY LEAD