BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1991337 · Received February 15, 2011

    Report

    Report Number
    2649622-2011-02358
    Event Type
    Injury
    Date Received
    February 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS DISLODGMENT OF THE ATRIAL LEAD . THE LEAD WAS REPOSITIONED AND REMAINS IN USE. DURING THE REPOSITIONING PROCEDURE, THERE WAS DIFFICULTY TIGHTENING THE DEVICE HEADER SET SCREW. THE PHYSICIAN BACKED OUT ONE OF THE SET SCREWS TOO FAR AND IT BECAME MISALIGNED WITH THE THREADS AND COULD NOT BE SEAT PROPERLY DUE TO THE ANGLE OF THE GROMMET. THE DEVICE WAS EXTRACTED AND REPLACED. 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. 4076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R 4076 IMPLANTABLE PACING LEAD