BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 1861615 · Received October 8, 2010

    Report

    Report Number
    2649622-2010-10012
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    June 15, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S039
    Removal / Correction Number
    ASKU
    Adverse Event
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED INAPPROPRIATE HIGH VOLTAGE THERAPY SHOCKS DUE TO OVERSENSING. THE MEASURED PACING LEAD IMPEDANCE VALUE ON THE LEAD WAS HIGH (>3000 OHM). THE SENSING INTEGRITY COUNTER (SIC) OF THE ICD REGISTERED A HIGH NUMBER OF SHORT INTERVALS. THE PATIENT WISHED TO DEACTIVATE THE COMPLETE SYSTEM. PATIENT ALERT WAS PROGRAMMED OFF AND THE PATIENT WILL DISCUSS SYSTEM EXPLANT WITH THE PHYSICIAN. IT WAS LATER REPORTED THAT THE SYSTEM IS STILL IMPLANTED, BUT HAS BEEN DEACTIVATED. THE DATE OF DEACTIVATION IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS WERE 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 Required Intervention (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB