BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3153360 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05956
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 27, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE LEAD WAS RETURNED IN SEGMENTS, ANALYZED, AND THE SVC (SUPERIOR VENA CAVA) DEFIBRILLATION COIL DEVELOPED A FRACTURE DUE TO FLEXING WHILE IN VIVO.

    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: PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. HIGH RESISTANCE/IMPEDANCE WAS NOTED. ONE PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE OCCURRED ON (B)(6) 2013. DAILY HIGH VOLTAGE LEAD TREND DATA SHOWS AN INCREASE FOR SUPERIOR VENA CAVA (SVC) DEFIB IMPEDANCE OF 49 TO 212 OHMS PEAK BETWEEN (B)(6) 2013. (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)  (B)(6) 2009. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) SUPERIOR VENA CAVA (SVC) COIL HAD HIGH IMPEDANCE AND AN ALERT WAS TRIGGERED. 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
    255336 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Hospitalization| R