BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2812720 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15954
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    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 FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE DEFIBRILLATION CONDUCTOR WAS CUT, THE OUTER TUBING OVERLAY MELTED AND HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THE INNER AND OUTER INSULATION WERE BREACHED CUT, AND THE OUTER INSULATION HAD A COSMETIC DEPRESSION. THE ANALYST COMMENTED THAT THE LEAD WAS DESTRUCTIVELY ANALYZED BUT NO FRACTURE WAS OBSERVED. THE RV DEFIBRILLATION CONDUCTOR WAS CUT, NOT FRACTURED. ALL OF THE CONDUCTORS WERE PULLED OUT AND THERE WERE NO SIGNS OF WEAR ON ANY CONDUCTORS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A RIGHT VENTRICULAR (RV) LEAD FRACTURE, WITH THE RV COIL IMPEDANCE HIGH, THE SUPERIOR VENA CAVA (SVC) COIL IMPEDANCE NOT MEASURABLE, AND THE PACE/SENSE IMPEDANCE HIGH ACROSS ONE VECTOR AND NORMAL ACROSS ANOTHER. THE RV LEAD WAS EXPLANTED 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

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD| 6937A IMPLANTABLE TACHY LEAD| D314DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB