BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2201981 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11249
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. NO ANOMALIES WERE FOUND. BLOOD/BODY FLUID WAS FOUND ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), AND BLOOD WAS FOUND IN/ON THE HELIX/LOBE MECHANISM AND THE HELIX/LOBE MECHANISM (SLEEVE HEAD). THE OUTER INSULATION WAS BREACHED CUT AND EXHIBITED COSMETIC DEPRESSION. THERE WAS APPARENT EXPLANT DAMAGE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD DISLODGED AND HAD NO SENSING AND PACING. THE LEAD WAS REMOVED AND REPLACED. 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 68 YR Hospitalization| R 4194 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB