BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE

    MDR report key: 2863862 · Received December 10, 2012

    Report

    Report Number
    2182208-2012-04056
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    November 16, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 2009 (B)(6). (B)(4). THE LEAD REMAINS IN USE AND HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR LEAD HAD NOISE AND WAS OVERSENSING. REPROGRAMMING WAS DISCUSSED, HOWEVER IS HAS BEEN DECIDED NOT TO MAKE ANY CHANGES AND CONTINUE TO MONITOR. THE VENTRICULAR 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
    1 CAPSURE ELECTRODE, PACEMAKER, PERMANENT DTB RICE CREEK MFG 4968-35

    Patients

    Seq Age Sex Outcome Treatment
    1 00008 YR (B)(4) IMPLANTABLE PULSE GENERATOR (IPG)