BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2810479 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15989
    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 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 FULL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED; ANALYSIS REVEALED THE DISTAL CONDUCTOR WAS FRACTURED. THE DEFIB CONDUCTOR WAS DISTORTED AND THERE WAS COSMETIC ENVIRONMENTAL STRESS CRACKING AND A BREACHED CUT ON THE OUTER TUBING OVERLAY. THERE WAS ALSO A COSMETIC DEPRESSION ON THE OUTER INSULATION, BLOOD IN/ON THE HELIX MECHANISM, AND THE LEAD WAS FLEXED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED INAPPROPRIATE THERAPY DUE TO THE RIGHT VENTRICULAR LEAD BEING "BROKEN." THE IMPEDANCE WAS HIGH AND THE LEAD WAS OVERSENSING. THE LEAD WAS EXPLANTED AND REPLACED. NO FURTHER 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 69 YR Hospitalization| L| R 7274 IMPLANTABLE PACEMAKER/CARDIO/DEFIB