BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP NOVUS

    MDR report key: 3153759 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06206
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 28, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, 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. PRODUCT: 694465 IMPLANTABLE TACHY LEAD - (B)(6) 2003; 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB - (B)(6) 2005. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PARTIAL LEAD IN SEGMENTS WAS RETURNED AND ANALYZED. A PROXIMAL PORTION WAS RECEIVED MEASURING 7.5 CM. A MEDIAL PORTION WAS RECEIVED MEASURING 7.5 CM. A DISTAL PORTION WAS RECEIVED MEASURING 7.5 CM. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS BEING HOSPITALIZED FOR SEPTICEMIA AND THEIR DEVICE HAS NOT BEEN CHECKED SINCE MAY 2010. UPON INTERROGATION OF THE PATIENT'S DEVICE IT WAS FOUND THAT THE RIGHT VENTRICULAR LEAD HAD HIGH IMPEDANCE, INCREASED THRESHOLD, AND OVERSENSING. THE LEAD WAS EXPLANTED. IT WAS ALSO REPORTED THAT DUE TO THE PATIENT'S SEPSIS THE DEVICE AND THE ATRIAL LEAD WERE ALSO REMOVED. IT WAS ALSO NOTED THAT THE DEVICE WAS APPROACHING ELECTIVE REPLACEMENT INDICATOR (ERI). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258268 CAPSURE SP NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4592-53

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Hospitalization| R