BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 1790963 · Received August 10, 2010

    Report

    Report Number
    2182208-2010-00425
    Event Type
    Injury
    Date Received
    August 10, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P920015/S13
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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) DISTAL CONDUCTOR FRACTURED; PROXIMAL SEGMENT WAS RECEIVED FOR ANALYSIS. OUTER INSULATION WAS FOUND BREACHED CUT. PERFORMANCE DATA COLLECTED FROM THE DEVICE REVEALED HIGH VENTRICULAR IMPEDANCE. THE VENTRICULAR PACE IMPEDANCE WAS AROUND 400 OHMS UNTIL THE WEEK ENDING (B)(6) 2008 WHEN THE MAX VALUE WAS 1468 OHMS. THIS MAX VALUE REMAINED ELEVATED THROUGH THE END OF THE RECORD (B)(6) 2009. THE RANGE OVER THIS TIME WAS 1468. INTERFERENCE/NOISE ALSO WAS OBSERVED. THE LIFETIME VENTRICULAR SENSING INTEGRITY COUNTER IS 25,249. A HIGH VALUE OF THIS COUNT CAN INDICATE A POSSIBLE INTERMITTENCY IN THE SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS OVERSENSING OF NOISE, AN IMPEDANCE SPIKE TO HIGH IMPEDANCE OF 1800 OHMS, AND FLUCTUATING IMPEDANCE. THE LEAD WAS EXPLANTED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPRINT IMPLANTABLE TACHY LEAD LWS MEDTRONIC, INC. 6943 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 7227CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB