BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1861418 · Received October 8, 2010

    Report

    Report Number
    2649622-2010-09970
    Event Type
    Injury
    Date Received
    October 8, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    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 FULL LEAD WAS RETURNED AND ANALYZED WITH A TIP SEAL OBSERVATION. IT WAS NOTED THAT THERE WAS BLOOD IN ON THE HELIX/LOBE MECHANISM AND THE HELIX WAS DISENGAGED FROM THE HELICAL CHANNEL. THE HELIX WILL NOT EXTEND DUE TO BEING OVER RETRACTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 6947 LEAD WAS RETURNED WITH NO INFORMATION. SUBSEQUENT FOLLOW-UP WITH A CLINICIAN INDICATED THAT THE 6947 LEAD WAS REPLACED AS THE HELIX MECHANISM WOULD NOT DEPLOY. IN ADDITION, THEY REPORTED THAT THE 4076 ATRIAL LEAD WAS REPOSITIONED, AS IT HAD BECOME DISLODGED. NO PATIENT COMPLICATIONS HAVE BEEN 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 Required Intervention 6550 NON-MD IMPLANTABLE PACEMAKER/CARDIO/DEFIB