BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2051516 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05577
    Event Type
    Injury
    Date Received
    April 12, 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
    CA, 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, ANALYZED, AND THE DISTAL CONDUCTOR HAD FRACTURED. IT WAS ALSO NOTED THAT THE DEFIBRILLATOR CONDUCTOR WAS DISTORTED AND HAD A CONDUCTOR FRACTURE DUE TO OVERSTRESS, THERE WAS BLOOD/BODY FLUID IN THE OUTER TUBING OVERLAY, THE INNER TUBING WAS KINKED/BUCKLED, THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE OUTER TUBING HAD ENVIRONMENTAL STRESS CRACKING BREACH/NON ELECTRICAL BREACH, THE OUTER TUBING OVERLAY WAS BREACHED CUT, THE EXPOSED DEFIBRILLATOR COIL HAD A WHITE SUBSTANCE, THE OUTER INSULATION HAD A COSMETIC DEPRESSION, AND THERE WAS BLOOD IN/ON THE HELIX MECHANISM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE SHOCKS. IT WAS ALSO REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD OVERSENSING, HIGH IMPEDENCE, AND A FRACTURE WAS SUSPECTED. THE LEAD WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE 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 53 YR Hospitalization| L| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB