BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 1921704 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12655
    Event Type
    Injury
    Date Received
    December 13, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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 SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. THE DISTAL CONDUCTOR WAS FRACTURED. IT WAS NOTED THAT ALL CONDUCTORS WERE DISTORTED AND BLOOD/BODY FLUID WAS PRESENT (NOT OBSTRUCTED), ALL INSULATORS HAD COSMETIC METAL ION OXIDATION, THE INNER INSULATION WAS BREACHED DUE TO METAL ION OXIDATION, THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING AND WAS BREACHED CUT. A WHITE SUBSTANCE WAS ALSO NOTED. (B)(4): THE DISTAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. INNER INSULATION BREACHED DUE TO METAL ION OXIDATION AND BLOOD/BODY FLUID WAS NOTED ON ALL CONDUCTORS (NOT OBSTRUCTED). ALSO NOTED WERE MELTING, COSMETIC METAL ION OXIDATION, ENVIRONMENTAL STRESS CRACKING, AND BREACH CUT OF THE OUTER INSULATION. IT WAS FURTHER NOTED THAT A WHITE SUBSTANCE WAS PRESENT ON THE OUTER INSULATION AND THERE WAS BLOOD IN/ON THE HELIX MECHANISM. THE ANALYST COMMENTED THAT LARGE WHITE DEPOSITS WERE FOUND ON THE RING AND THERE WAS A LARGE METAL ION OXIDATION BREACH (APPROX. 2CM LONG).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BOTH THE ATRIAL LEAD AND VENTRICULAR LEAD HAD OVERSENSING, HIGH THRESHOLDS, AND DECREASING IMPEDANCES. BOTH LEADS WERE EXPLANTED AND REPLACED. 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 IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 4068 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Hospitalization| R E2DR31 IMPLANTABLE PULSE GENERATOR