BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2202142 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11278
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P980016
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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 DISTAL PORTION OF THE LEAD WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR WAS FRACTURED. IT WAS NOTED THAT THE DEFIBRILLATION CONDUCTOR WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON SEVERAL CONDUCTORS (NOT OBSTRUCTED), THE INNER TUBING WAS KINKED/BUCKLED, THE OUTER INSULATION WAS BREACHED CUT, THERE WAS A WHITE SUBSTANCE ON THE OUTER INSULATION, THE HELIX/LOBE WAS DISTORTED/BENT AND THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIUM (RA) LEAD HAD AN APPARENT LEAD FRACTURE AND WHEN THE SUTURE WAS REMOVED FROM THE SUTURE SLEEVE THE PROXIMAL PORTION OF THE LEAD CAME OFF AND THE DISTAL PORTION OF THE LEAD WENT DEEPER IN THE SUBCUTANEOUS TISSUE AND WAS UNABLE TO BE REACHED FOR EXTRACTION. THE RA LEAD WAS CAPPED AND PARTIALLY REMOVED. THE RA LEAD WAS NOT REPLACED DUE TO PATIENT GOING FROM A DUAL CHAMBER TO SINGLE CHAMBER DEVICE. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD NOISE, OVERSENSING, HIGH IMPEDANCE, AND A POSSIBLE LEAD FRACTURE. THE RV 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 IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 6940 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB