BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 3992146 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02416
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 3, 2014
    Report Date
    May 3, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DISTAL PORTION OF THE LEAD WAS RETURNED, ANALYZED AND THERE WAS BLOOD ON A DEFIBRILLATION CONDUCTOR AND IT WAS NOT OBSTRUCTED. THE OUTER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO A DEPRESSION WHILE IN VIVO. THE INNER INSULATION OF THE LEAD DEVELOPED A DEPRESSION BREACH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED AFTER RECEIVING INAPPROPRIATE THERAPY. IT WAS DETERMINED THAT THE RIGHT VENTRICULAR (RV) LEAD EXPERIENCED OVERSENSING AT THE TIME OF A PREVIOUS GENERATOR CHANGE IN 2010, HOWEVER WAS NOT ACTED UPON AS IT WAS THOUGHT THAT THERE WAS AIR IN THE HEADER. THERE WERE NO OTHER REPORTED ISSUES UNTIL AFTER A VENTRICULAR TACHYCARDIA (VT) STORM, IN WHICH OVERSENSING POST-SHOCK WAS DETECTED. IN ADDITION, THERE WAS A SLIGHT INCREASE IN SHORT INTERVAL COUNTS (SIC). AN INSULATION BREACH IS SUSPECTED ALONG WITH LEAD TO LEAD INTERACTION BETWEEN A PREVIOUS LEAD IN SITU BUT NOT CONNECTED. THE DECISION WAS MADE TO EXPLANT AND REPLACE THE RV LEAD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469646 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 6945

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 6936 LEAD