BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2203277 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-11680
    Event Type
    Injury
    Date Received
    August 11, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    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 FULL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. ANALYSIS REVEALED THAT THE DEFIBRILLATION CONDUCTOR WAS FRACTURED. THERE WAS BLOOD/BODY FLUID (NOT OBSTRUCTED) ON THE DEFIBRILLATION CONDUCTOR AND THE DEFIBRILLATION CONDUCTOR WAS DISTORTED. THE INNER TUBING WAS KINKED/BUCKLED, THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, AND THE OUTER TUBING HAD ENVIRONMENTAL STRESS CRACKING BREACH (NON-ELECTRICAL.) THE OUTER INSULATION WAS TORN AND HAD A COSMETIC DEPRESSION. THERE WAS BLOOD IN/ON THE HELIX MECHANISM SLEEVE HEAD AND ON THE HELIX MECHANISM ITSELF. THE LEAD WAS STRETCHED AND HAD A TENSILE FLEX FRACTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD HIGH IMPEDANCE. THE LEAD WAS REMOVED AND 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 SPRINT QUATTRO SECURE IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6947 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R 7232CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB