BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2813305 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16263
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S24
    Removal / Correction Number
    Z-0475-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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 IN SEGMENTS WAS RETURNED TO THE MANUFACTURER AND ANALYZED. THE INNER INSULATION WAS TORN. ALL CONDUCTORS AND THE DEFIBRILLATION CONDUCTOR WERE DISTORTED. THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING (ESC.) THE OUTER INSULATION WAS BREACHED CUT AND HAD COSMETIC DEPRESSION. THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THE LEAD HAD APPARENT EXPLANT DAMAGE. EVALUATION SUMMARY (B)(4): THE FULL LEAD WAS RETURNED TO THE MANUFACTURER AND ANALYZED. THE OUTER INSULATION BREACHED CUT AND ALL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THE LEAD HAD DAMAGE AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS EXTRACTED DUE TO CHRONIC LOW R-WAVES, INCREASED THRESHOLDS, T-WAVE OVERSENSING, AND QUESTIONABLE PLACEMENT THAT COULD CAUSE VENTRICULAR TACHYCARDIA. DURING RV LEAD REPLACEMENT, THE NEWLY ATTEMPTED LEAD WAS INJURED DURING IMPLANT AS A SMALL PORTION OF THE SHEATH STAYED ON THE LEAD AFTER PEELING AND THE LEAD WAS INJURED WHILE CUTTING. THE ATTEMPTED RV LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. 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 36 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB