BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 4970004 · Received August 5, 2015

    Report

    Report Number
    2649622-2015-08714
    Event Type
    Malfunction
    Date Received
    August 5, 2015
    Date of Event
    June 20, 2015
    Report Date
    June 22, 2015
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED, AND THE EXPOSED SVC (SUPERIOR VENA CAVA) DEFIBRILLATION COIL HAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY : ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCES ON THE RV (RIGHT VENTRICULAR) DEFIBRILLATION COIL AND SVC (SUPERIOR VENA CAVA) DEFIBRILLATION COIL WERE BEYOND THE EXPECTED LOWER RANGE. ANALYSIS OF THE DEVICE MEMORY INDICATED OVERSENSING DUE TO NON-PHYSIOLOGIC SIGNALS/SIC (SENSING INTEGRITY COUNTER). IMPEDANCE ON 2015-06-20, RV DEFIB COIL IMPEDANCE MEASURED LESS THAN 20 OHMS AND SVC DEFIB COIL IMPEDANCE MEASURED LESS THAN 20 OHMS. SENSING-SICS SINCE LAST SESSION, BEGINNING (B)(6) 2015, 92 VENTRICULAR SENSING INTEGRITY COUNTS (SIC) OCCURRED. (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT'S RIGHT VENTRICULAR (RV) LEAD WAS EXPLANTED AND REPLACED FOR LOW IMPEDANCE ON THE SUPERIOR VENA CAVA (SVC) AND RIGHT VENTRICULAR (RV) COILS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LEAD INTEGRITY ALERT (LIA) TRIGGERED DUE TO A ONE-TIME OCCURRENCE OF LOW IMPEDANCE READINGS ON BOTH SUPERIOR VENA CAVA (SVC) AND RIGHT VENTRICULAR (RV) COILS. THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518291 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Hospitalization| R