BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3156012 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-07353
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    April 18, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: D284DRG, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, (B)(6) 2009; 4574, IMPLANTABLE PACING LEAD, (B)(6) 2009. (B)(4).

    Additional Manufacturer Narrative · 1

    THE PARTIAL LEAD WAS RETURNED IN SEGMENTS, ANALYZED, AND NO ANOMALIES WERE FOUND. ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE RV (RIGHT VENTRICULAR) DEFIBRILLATION COIL WAS BEYOND THE EXPECTED UPPER RANGE. PRODUCT PERFORMANCE INFORMATION WAS ALSO ANALYZED AND ANALYSIS OF THE DEVICE MEMORY INDICATED THE IMPEDANCE ON THE SVC (SUPERIOR VENA CAVA) DEFIBRILLATION COIL WAS BEYOND THE EXPECTED UPPER RANGE. ONE PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE OCCURRED ON (B)(6) 2011. THE WEEKLY HIGH VOLTAGE LEAD TREND DATA SHOW AN INCREASE FOR MINIMUM AND MAXIMUM DEFIBRILLATION ACTIVE CAN ON AND SVC DEFIBRILLATION IMPEDANCE WAS 54 TO 254 OHMS PEAK BETWEEN (B)(6) 2011 AND (B)(6) 2013.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RV COIL AND SCV COIL IMPEDANCES ON THE RIGHT VENTRICULAR LEAD WERE HIGH. THE DEVICE WAS ALSO NOTED TO HAVE DECREASED LONGEVITY. BOTH THE LEAD AND DEVICE WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RV COIL AND SCV COIL IMPEDANCES ON THE RIGHT VENTRICULAR LEAD WERE HIGH. THE DEVICE WAS ALSO NOTED TO HAVEDECREASED LONGEVITY. BOTH 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
    256729 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Hospitalization| R