BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3400137 · Received October 10, 2013

    Report

    Report Number
    2649622-2013-11867
    Event Type
    Injury
    Date Received
    October 10, 2013
    Date of Event
    July 20, 2013
    Report Date
    July 21, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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: D334DRG, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, (B)(6) 2011; 5076, IMPLANTABLE PACING LEAD, (B)(6) 2003. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXPERIENCING HIGH THRESHOLDS AND HIGH SUPERIOR VENA CAVA (SVC) IMPEDANCE TRIGGERED A PATIENT ALERT. THE LEAD WAS REPROGRAMMED WITH THE SCV COIL OFF, WHICH RESOLVED THE ISSUE. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517056 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention