BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT

    MDR report key: 3152455 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-06792
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    October 1, 2008
    Report Date
    March 28, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. ANALYSIS REVEALED NO ANOMALIES WERE FOUND. THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT AND TEAR. THE ANALYSIS OF THE DEVICE MEMORY INDICATED LEAD IMPEDANCE OUT OF RANGE ALERT WAS TRIGGERED. THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER) WAS ALSO INDICATED. THE VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. ANALYSIS OF THE PERFORMANCE DATA COLLECTED FROM THE DEVICE REVEALED 3 NON-SUSTAINED TACHYCARDIA EPISODES OF LESS THAN 220MS V-V CYCLE RECORDED BETWEEN 26 NOV 2012 AND 23 MAR 2013. AN OUT OF TOLERANCE (OOT) SUB THRESHOLD LEAD IMPEDANCE ALERT WAS RECORDED ON (B)(6) 2009 AND (B)(6) 2010 AND (B)(6) 2011. THE MAXIMUM RV PACE LEAD IMPEDANCE RISES AND VARIES FROM AN APPROXIMATE BASELINE OF 800 OHMS TO GREATER THAN 2,000 OHMS BETWEEN (B)(6) 2011 AND THE DATE OF EXPLANT. THE ANALYST NOTED THAT OTHER THAN NON-SEVERE EXPLANT DAMAGE, THERE WERE NO ANOMALIES OBSERVED ON THE RETURNED FULL LEAD IN SEGMENTS. ALL ELECTRICAL TESTING WAS WITHIN SPECIFIED PARAMETERS.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS INTERMITTENT HIGH RIGHT VENTRICULAR (RV) LEAD IMPEDANCE AND NOISE OBSERVED APPROXIMATELY THREE MONTHS AFTER THE DEVICE WAS REPLACED. IT WAS FURTHER REPORTED THAT THE RV LEAD WAS TESTED THROUGH THE ANALYZER AND ALL ELECTRICAL MEASUREMENTS WERE FOUND TO BE WITHIN NORMAL RANGE AND THAT THE PHYSICIAN SUSPECTED A CONNECTION ISSUE WITH THE DEVICE. THE LEAD AND DEVICE WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252719 SPRINT DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 69436536

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R C174AWK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (IC