BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3991468 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08100
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 8, 2014
    Report Date
    October 24, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Removal / Correction Number
    Z-0474-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) PACING LEAD WAS BEYOND THE EXPECTED UPPER RANGE. ANALYSIS OF THE DEVICE MEMORY INDICATED A LEAD IMPEDANCE OUT OF RANGE ALERT. AN OUT OF TREND SUBTHRESHOLD LEAD IMPEDANCE ALERT OCCURRED ON (B)(6) 2014. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE TREND ON THE RV PACING LEAD WAS VARIABLE. MAXIMUM RV PACING IMPEDANCE VARIES BETWEEN 720 AND 2544 OHMS BETWEEN THE WEEKS ENDING (B)(6) 2014; 4691 OF 4695 LIFETIME VENTRICULAR SHORT INTERVAL COUNTS (SIC) ARE RECORDED BEGGING IN (B)(6) 2014. THERE ARE 15 NON-SUSTAINED TACHYCARDIA EVENTS OF LESS THAN 220MS V-V CYCLE RECORDED BETWEEN (B)(6) 2014.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCTS: (B)(4), ICD IMPLANTED: 2008 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE WAS HIGH AND THE RV LEAD WAS OVERSENSING. THE LEAD PROGRAMMING WAS CHANGED. WITHIN TWO WEEKS THE HIGH IMPEDANCE AND OVERSENSING PERSISTED. A LEAD FRACTURE WAS CONFIRMED. THE PHYSICIAN CAPPED AND REPLACED THE RV LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470910 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Hospitalization| R 407652, LEAD