BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2130097 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10107
    Event Type
    Injury
    Date Received
    June 16, 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
    TX, 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, ANALYZED AND NO ANOMALIES FOUND. (B)(4) THE FULL LEAD WAS RETURNED AND ANALYZED. OUTER INSULATION WAS BREACHED (CLAVICLE-RIB CRUSH). 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 EXHIBITED COSMETIC DEPRESSION, AND THE LEAD APPEARED CRUSHED. (B)(4) THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. BLOOD/BODY FLUID WAS FOUND ON THE OUTER TUBING OVERLAY, AND BLOOD WAS FOUND IN/ON THE HELIX/LOBE MECHANISM AND THE HELIX/LOBE MECHANISM (SLEEVE HEAD). THE OUTER TUBING OVERLAY WAS MELTED, AND A WHITE SUBSTAND WAS FOUND ON THE OUTER INSULATION. THE INNER TUBING WAS KINKED/BUCKLED, AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4) THE FULL LEAD WAS RETURNED AND ANALYZED. THE OUTER INSULATION WAS BREACHED (CLAVICLE-RIB CRUSH), WAS BREACHED CUT AND COSMETIC CUT, AND EXHIBITED A COSMETIC DEPRESSION. THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), AND BLOOD WAS FOUND IN/ON THE HELIX/LOBE MECHANISM AND THE HELIX/LOBE MECHANISM (SLEEVE HEAD). THE LEAD ALSO APPEARED CRUSHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO T-WAVE OVERSENSING ON THE RIGHT VENTRICULAR (RV) LEAD. THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED AND A NEW PACE/SENSE LEAD WAS IMPLANTED. THE RV PACE/SENSE LEAD LATER HAD NOISE AND AN APPARENT FRACTURE. IT WAS ALSO REPORTED THAT THE DEVICE HAD A POTENTIAL HEADER ISSUE. THE ENTIRE SYSTEM WAS EXPLANTED AND REPLACED. THE RIGHT ATRIAL LEAD WAS RETURNED, ANALYZED, AND TESTED OUT OF SPECIFICATION. NO FURTHER 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 57 YR Hospitalization| L| R