BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1926216 · Received December 14, 2010

    Report

    Report Number
    2649622-2010-14234
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    October 15, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER INSULATION WAS BREACHED CUT, THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND THE LEAD WAS DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATTEMPTED IMPLANT THE LEAD WAS DISLODGED, TISSUE WAS CAUGHT IN THE HELIX AND IT WOULD NOT EXTEND OR RETRACT. THE LEAD WAS REMOVED AND ANOTHER LEAD WAS SUCCESSFULLY IMPLANTED. 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. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other