BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO

    MDR report key: 3152055 · Received June 7, 2013

    Report

    Report Number
    2649622-2013-05547
    Event Type
    Malfunction
    Date Received
    June 7, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 1, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCT EVENT SUMMARY : INITIALLY THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION, HOWEVER PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND ANALYZED. ANALYSIS REVEALED NON-PHYSIOLOGIC OVERSENSING. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR PACING IMPEDANCE WAS RISING. MODEL 5076, IMPLANTABLE PACING LEAD, IMPLANTED 2004 (B)(6). (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY #(B)(4) - THE DISTAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THAT THE PROXIMAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DISTAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THAT THE PROXIMAL CONDUCTOR OF THE LEAD DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A REMOTE MONITORING TRANSMISSION ALERT WAS RECEIVED BY THE HOSPITAL. IT WAS OBSERVED REMOTELY THAT THE RIGHT VENTRICULAR (RV) IMPLANTABLE DEFIBRILLATION LEAD EXHIBITED RISING IMPEDANCE AND THRESHOLD INCREASE AND MULTIPLE SHORT VENTRICULAR-VENTRICULAR (V-V) INTERVALS WERE DETECTED. A POTENTIAL LEAD FRACTURE IS SUSPECTED. NOISE WAS ALSO NOTED IN THE BIPOLAR CONFIGURATION. THE LEAD WAS 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
    252889 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Hospitalization| R (B)(4), IMPLANTABLE CARDIOVERTER DEFIBRILLATOR