BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2051093 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05481
    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
    NC, 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 INNER INSULATION WAS BREACHED AND HAD METAL ION OXIDATION. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THERE WAS BLOOD/BODY FLUID ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED), THE INNER INSULATION HAD COSMETIC METAL ION OXIDATION, THE OUTER INSULATION WAS BREACHED AND HAD ENVIRONMENTAL STRESS CRACKING, THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE HELIX/LOBE WAS DISTORTED/BENT, THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THE TIP SEAL WAS OBSERVED TO BE OUT OF POSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD WAS REMOVED AND REPLACED DUE TO HIGH THRESHOLD AND LOW IMPEDANCE. 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 58 YR Hospitalization| R 7278 IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6945 IMPLANTABLE TACHY LEAD| 6945 IMPLANTABLE TACHY LEAD