BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2200642 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11037
    Event Type
    Injury
    Date Received
    August 11, 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
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY FOR (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND THE INNER INSULATION WAS BREACHED DUE TO METAL INDUCED OXIDATION (MIO). THE LEAD HAD A LOT OF EXPLANT DAMAGE AND WAS VERY STRETCHED. IT WAS NOTED THAT ALL CONDUCTORS WERE STRETCHED. THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED). THE DISTAL CONDUCTOR FRACTURED DUE TO OVERSTRESS. THE OUTER INSULATION WAS MELTED. THE INNER AND OUTER INSULATION HAD COSMETIC METAL INDUCED OXIDATION, AND THE OUTER INSULATION HAD BREACHED METAL INDUCED OXIDATION. THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING AND THE LEAD WAS STRETCHED. EVALUATION SUMMARY FOR (B)(4): THE LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND THE PROXIMAL CONDUCTOR FRACTURED. THE LEAD HAD A LOT OF EXPLANT DAMAGE AND WAS VERY STRETCHED. IT WAS NOTED THAT ALL OF THE CONDUCTORS WERE DISTORTED, ALL CONDUCTORS WERE STRETCHED, THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), THE INNER INSULATION WAS KINKED/BUCKLED, THE OUTER INSULATION WAS MELTED, THE INNER AND OUTER INSULATION HAD COSMETIC MIO , THE INNER INSULATION WAS BREACHED DUE TO MIO , THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE INNER INSULATION WAS TORN, THE OUTER INSULATION WAS BREACHED CUT, THERE WAS A WHITE SUBSTANCE ON THE OUTER INSULATION, THE OUTER INSULATION HAD A COSMETIC DEPRESSION AND THE LEAD WAS STRETCHED.

    Description of Event or Problem · 1

    TWO LEADS WERE RETURNED TO THE MANUFACTURER WITH NO CLAIMS OF PATIENT COMPLICATIONS. THE RIGHT VENTRICULAR LEAD WAS NOTED TO HAVE BEEN SWITCHED TO UNIPOLAR, BUT THE CAUSE FOR THIS SWITCH IS UNKNOWN. THE LEADS WERE ANALYZED AND TESTED OUT OF SPECIFICATION. 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. 4568 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| R ADDR01 IMPLANTABLE PULSE GENERATOR