BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SP

    MDR report key: 2051533 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05575
    Event Type
    Injury
    Date Received
    April 12, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S15
    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 PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON SEVERAL CONDUCTORS (NOT OBSTRUCTED), THE INNER TUBING WAS KINKED/BUCKLED, THE OUTER INSULATION HAD A COSMETIC CUT, THERE WAS A WHITE SUBSTANCE ON THE EXPOSED DEFIBRILLATION COIL, THERE WAS A WHITE SUBSTANCE ON THE OUTER INSULATION, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THE HELIX/LOBE WAS DISTORTED/BENT, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4): THE LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), THE OUTER INSULATION WAS PARTIALLY OR FULLY COVERING THE TIP ELECTRODE, THE OUTER INSULATION WAS BREACHED CUT, THERE WAS A WHITE SUBSTANCE ON THE OUTER INSULATION, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THERE WAS APPARENT EXPLANT DAMAGE. (B)(4): THE DISTAL PORTION OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE PROXIMAL CONDUCTOR WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), THE INNER INSULATION WAS PULLED APART DUE TO OVERSTRESS, THE OUTER INSULATION WAS PARTIALLY OR FULLY COVERING THE TIP ELECTRODE, THE OUTER INSULATION HAD A COSMETIC CUT, THE OUTER INSULATION WAS BREACHED CUT, THERE WAS A WHITE SUBSTANCE ON THE OUTER INSULATION, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, THERE WAS APPARENT EXPLANT DAMAGE AND THE LEAD WAS STRETCHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) HIGH VOLTAGE LEAD HAD HIGH THRESHOLDS. IT WAS FURTHER REPORTED THAT WHEN EXTRACTING THE RV HIGH VOLTAGE LEAD THE RIGHT VENTRICULAR AND RIGHT ATRIAL PACING LEADS WERE ADHERED TO IT AS WERE EXPLANTED AS WELL. ALL LEADS WERE 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 CAPSURE SP IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5024M ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB