BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2051264 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05528
    Event Type
    Injury
    Date Received
    April 12, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S2
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 FOR (B)(4): THE LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE OUTER INSULATION WAS BREACHED AND HAD A DEPRESSION. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR WAS CUT, ALL CONDUCTORS WERE STRETCHED, THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), THE DEFIBRILLATION CONDUCTOR FRACTURED DUE TO OVERSTRESS, THE INNER INSULATION WAS KINKED/BUCKLED, THE OUTER INSULATION WAS KINKED/BUCKLED, THERE WAS A WHITE SUBSTANCE ON THE OUTER INSULATION, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THE HELIX WAS DISTORTED/BENT, THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND THE LEAD WAS STRETCHED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A QUESTION ABOUT A POTENTIAL FRACTURE OF A RIGHT VENTRICULAR PACING LEAD. THE LEAD HAD VARYING IMPEDANCE AND IMPEDANCES THAT SPIKED TO GREATER THAN 2,000 OHMS. IT WAS ALSO NOTED THAT THE LEAD WAS PLUGGED INTO THE LEFT VENTRICULAR LEAD PORT OF THE DEVICE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A QUESTION ABOUT A POTENTIAL FRACTURE OF A RIGHT VENTRICULAR PACING LEAD. THE LEAD HAD VARYING IMPEDANCE AND IMPEDANCES THAT SPIKED TO GREATER THAN 2,000 OHMS. IT WAS ALSO NOTED THAT THE LEAD WAS PLUGGED INTO THE LEFT VENTRICULAR LEAD PORT OF THE DEVICE. IT WAS LATER REPORTED THE LEAD WAS EXPLANTED 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. 5068 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| O| R 1821 COMPETITOR IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 1821 COMPETITOR IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4269 COMPETITOR IMPLANTABLE PACING LEAD| 4269 COMPETITOR IMPLANTABLE PACING LEAD| 4269 COMPETITOR IMPLANTABLE PACING LEAD| 1821 COMPETITOR IMPLANTABLE PACEMAKER/CARDIO/DEFIB