BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2964629 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02143
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    November 1, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) IMPLANTABLE PACING LEAD, (B)(6) 2002. (B)(4). LEAD WAS NOT RETURNED TO MANUFACTURER.

    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 CAME IN TO THE ER DUE TO FALL/POSSIBLE FALL. THE DEVICE WAS INTERROGATED AND THE RIGHT VENTRICULAR LEAD WAS FOUND TO BE FRACTURED. IT WAS NOTED THAT THE DEVICE SHOWED A LEAD WARNING 13 DAYS PRIOR TO THE FALL. ACCORDING TO THE PHYSICIAN THE PATIENT EXPERIENCED A FALL ON WITH A HEAD INJURY THAT INCLUDED STITCHES AND POSSIBLE STROKE ON (B)(6). ON (B)(6), THE PATIENT CAME TO ER WITH ANOTHER FALL AND POSSIBLE STROKE. A BRAIN CT SHOWED BLEEDING ON THE BRAIN. THE PATIENT WAS TRANSPORTED TO ANOTHER FACILITY FOR TRAUMA SURGERY. FOLLOW-UP IS IN PROGRESS TO DETERMINE RESULT OF SURGERY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66324 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Hospitalization| L| R (B)(4) IMPLANTABLE PULSE GENERATOR