BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 2203541 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-12355
    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
    MO, 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 FOR (B)(4): THE DISTAL SEGMENT WAS RETURNED AND ANALYZED AND THE INNER AND OUTER INSULATION HAD BREACHED METAL INDUCED OXIDATION. THERE WAS BLOOD/ BODY FLUID (NOT OBSTRUCTED) ON ALL CONDUCTORS AND THE CONDUCTORS WERE DISTORTED. THE OUTER INSULATION WAS MELTED AND HAD COSMETIC ENVIRONMENTAL STRESS CRACKING. THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND THE TIP SEAL WAS OBSERVED OUT OF POSITION.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE EVALUATION SUMMARY FOR (B)(4): THE DISTAL SEGMENT WAS RETURNED AND ANALYZED AND THE INNER AND OUTER INSULATION HAD BREACHED METAL INDUCED OXIDATION. THERE WAS BLOOD/ BODY FLUID (NOT OBSTRUCTED) ON ALL CONDUCTORS AND THE CONDUCTORS WERE DISTORTED. THE OUTER INSULATION WAS MELTED AND HAD COSMETIC ENVIRONMENTAL STRESS CRACKING. THERE WAS BLOOD IN/ON THE HELIX MECHANISM AND THE TIP SEAL WAS OBSERVED OUT OF POSITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THE ATRIAL LEAD HAD INCREASED THRESHOLDS AND HIGH IMPEDANCE. THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS WERE 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 70 YR Hospitalization| R 6949 IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6949 IMPLANTABLE TACHY LEAD| 4193 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 4193 IMPLANTABLE PACING LEAD