BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2955519 · Received February 11, 2013

    Report

    Report Number
    2182208-2013-00359
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Report Date
    December 5, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    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. CONCOMITANT PRODUCT : 4968 IMPLANTABLE PACING LEAD (B)(6) 2011. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR LEAD WAS OVERSENSING. IT WAS NOTED THAT THE PHYSICIAN IS AWARE OF THE SENSING ISSUE AND THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58632 ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG 4968-35

    Patients

    Seq Age Sex Outcome Treatment
    1 P1501DR IMPLANTABLE PACEMAKER