BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2954525 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-02323
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 20, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE.

    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).

    Additional Manufacturer Narrative · 1

    (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 APPROXIMATELY ONE WEEK AFTER THE IMPLANT PROCEDURE THE PATIENT REPORTED FEELING A "PULSATING" SENSATION IN THEIR ABDOMEN WHEN LYING ON THEIR SIDE OR BACK. UPON EVALUATION THE RIGHT VENTRICULAR LEAD WAS REPORTED TO HAVE LOW VENTRICULAR SENSING, NO VENTRICULAR CAPTURE AT THE MAXIMUM OUTPUT, AND THE LEAD WAS REPORTED TO HAVE DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED. IT WAS ALSO NOTED THAT THE PATIENT WAS ENROLLED IN THE (B)(4) STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY ONE WEEK AFTER THE IMPLANT PROCEDURE THE PATIENT REPORTED FEELING A "PULSATING" SENSATION IN THEIR ABDOMEN WHEN LYING ON THEIR SIDE OR BACK. UPON EVALUATION THE RIGHT VENTRICULAR LEAD WAS REPORTED TO HAVE LOW VENTRICULAR SENSING, NO VENTRICULAR CAPTURE AT THE MAXIMUM OUTPUT, AND THE LEAD WAS REPORTED TO HAVE DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED. IT WAS ALSO NOTED THAT THE PATIENT WAS ENROLLED IN THE (B)(6) STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT ALSO HAD A CARDIAC PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59402 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization| R (B)(4)