BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 3051002 · Received April 10, 2013

    Report

    Report Number
    2649622-2013-04789
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    February 27, 2013
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4) THE LEAD WAS NOT RETURNED. HOWEVER, PERFORMANCE DATA FROM THE DEVICE WAS ANALYZED AND REVEALED HIGHRIGHT VENTRICULAR (RV) PACING IMPEDANCE, RISING RV TREND PACING IMPEDANCE AND A LEAD IMPEDANCE OUT-OF-RANGE ALERT. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE PROXIMAL PORTION OF THE LEAD WAS RECEIVED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT A VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE. A PROXIMAL PORTION WAS RECEIVED MEASURING 11.5 CM. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD PACING IMPEDANCE IS RISING. THE LEAD REMAINS IN USE AND IS BEING MONITORED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    THE RV LEAD WAS CAPPED AND REPLACED DUE TO HIGH IMPEDANCE AND A FRACTURED PACE/SENSE PORTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153245 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R D154VWC IMPLANTABLE DEFIBRILLATOR