BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2791175 · Received October 15, 2012

    Report

    Report Number
    2649622-2012-14506
    Event Type
    Injury
    Date Received
    October 15, 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
    MI, 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 AND ANALYZED. NO ANOMALIES WERE FOUND. THE DISTAL CONDUCTOR WAS STRETCHED AND HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). THE OUTER INSULATION WAS MELTED, HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, AND WAS BREACHED CUT. THE LEAD WAS STRETCHED. VISUAL ANALYSIS NOTED THE LEAD HAD APPARENT EXPLANT DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS NOT IN THE HEADER OF THE NEWLY IMPLANTED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) PROPERLY. THE RV LEAD WAS ADJUST AND REMAINS IN USE. THE ICD ALSO REMAINS IN USE. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD WAS DAMAGED WHILE ADJUSTING THE RV LEAD. THE LV LEAD SHOWED INCREASED THRESHOLD AND LOW IMPEDANCE. THE LV LEAD WAS EXPLANTED AND WAS 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 68 YR Hospitalization| R 5076 IMPLANTABLE PACING LEAD