BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2790305 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14122
    Event Type
    Injury
    Date Received
    October 15, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A PROBABLE RIGHT ATRIAL (RA) LEAD DISLODGEMENT DUE TO HIGH THRESHOLDS, INTERMITTENT CAPTURE, AND NO SLACK NOTED ON A FLUOROSCOPY IMAGE. UPON OPENING THE POCKET, THE RA AND RIGHT VENTRICULAR (RV) LEADS WERE REPORTED TO HAVE HAD MULTIPLE TWISTS AND SUSPECTED TWIDDLING MAY HAVE OCCURRED. THE RV LEAD APPEARED TO HAVE INSULATION DAMAGE NOTED DURING THE OPENING OF THE POCKET AND IT WAS NOT KNOWN IF THIS WAS A RESULT OF OPENING THE POCKET OR THE SUSPECTED TWIDDLING. THE RA LEAD WAS REPOSITIONED AND THE RV LEAD WAS CAPPED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR