BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 3992682 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09732
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 8, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE 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 ALSO INDICATED A LEAD IMPEDANCE OUT OF RANGE ALERT. AN OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ALERT OCCURRED ON (B)(4) 2014. MAXIMUM RIGHT VENTRICULAR PACE IMPEDANCE RISES FROM 1112 OHMS THE WEEK ENDING (B)(4) 2014 TO GREATER THAN 4000 OHMS THE WEEK ENDING (B)(4) 2014.

    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 RIGHT VENTRICULAR (RV) LEAD TRIGGERED AN ALERT FOR A SUDDEN INCREASE TO HIGH IMPEDANCE. A FRACTURE WAS SUSPECTED. THE PHYSICIAN CONDUCTED A NON-INVASIVE PROGRAM STIMULATION PROCEDURE TO DETERMINE THE FUNCTIONALITY OF THE LEAD. THE PACING THRESHOLD WAS SLIGHTLY HIGHER THAN IT HAD BEEN BUT THE DEVICE ADEQUATELY DETECTED AND TREATED THE VENTRICULAR FIBRILLATION (VF). THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE LEAD WAS CAPPED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469282 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Hospitalization| R (B)(4) ICD