BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 2131950 · Received June 16, 2011

    Report

    Report Number
    2649622-2011-10608
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    December 1, 2009
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    Z-0474-2011
    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): THE DISTAL CONDUCTOR WAS FRACTURED. A PARTIAL PORTION OF THE LEAD WAS RETURNED IN SEGMENTS. ANALYSIS ALSO NOTED THE DEFIB CONDUCTOR DISTORTED, THE INNER TUBING KINKED/BUCKLED, AN OUTER INSULATION COSMETIC DEPRESSION, AND OUTER TUBING OVERLAY COSMETIC ENVIRONMENTAL STRESS CRACKING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD RISING THRESHOLDS. A PACE/SENSE LEAD WAS ADDED. THE HIGH VOLTAGE PORTION OF THE LEAD CONTINUED TO BE USED UNTIL IT WAS ELECTIVELY EXPLANTED AND REPLACED AT THE TIME OF A CONCOMITANT LEAD CHANGE OUT (B)(6) LATER. 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 S IMPLANTABLE TACHY LEAD LWS MEDTRONIC PUERTO RICO, INC. 6935 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB