BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 2811199 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16587
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S17
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) - A PARTIAL LEAD WAS RETURNED IN SEGMENTS AND ANALYSIS FOUND THAT THE PROXIMAL CONDUCTOR WAS FRACTURED. THE DEFIBRILLATOR CONDUCTOR WAS DISTORTED AND ALL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED). THE DEFIBRILLATOR CONDUCTOR WAS FRACTURED (OVERSTRESS). THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING AND WAS BREACHED CUT. THE OUTER INSULATION WAS TORN. VISUAL ANALYSIS NOTED THAT THE LEAD LENGTH IS UNKNOWN. ALL MEASUREMENTS WERE TAKEN FROM THE DISTAL TIP. THE INTERIOR RIGHT VENTRICULAR DEFIBRILLATOR CABLE FRACTURED (OVERSTRESS) AT 8CM. THE EXPOSED COIL CONTINUITY IS FRACTURED (OVERSTRESS) AT 1 CM. THE ANCHORING SLEEVE FIXATION SITE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTRICULAR LEAD HAD HIGH IMPEDANCE, NOISE AND OVERSENSING WHICH TRIGGERED A PATIENT ALERT. THE 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 IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6944

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R