BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE SENSE

    MDR report key: 2964799 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02030
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    December 8, 2012
    Report Date
    December 8, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    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. CONCOMITANT PRODUCTS: 5054-58 IMPLANTABLE PACING LEAD, (B)(6) 2012. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM COMPLAINING OF A "SICKING FEELING" IN THE LOWER ABDOMEN. HIGH THRESHOLDS ON BOTH LEADS WERE NOTED, ALONG WITH INTERMITTENT LOSS OF CAPTURE. THE RV (RIGHT VENTRICULAR) LEAD OUTPUT WAS REPROGRAMMED, AND BOTH LEADS REMAIN 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
    67017 CAPSURE SENSE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 457445

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR SEDR01 IMPLANTABLE PULSE GENERATOR