BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2951734 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00218
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    October 17, 2012
    Report Date
    November 5, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015/S024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, 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 PRODUCTS 5076 IMPLANTABLE PACING LEAD - 2012-(B)(6). (B)(4).

    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 PATIENT ALERTS WERE SOUNDING EVERY FOUR HOURS, AND IT WAS FOUND THAT THE SUPERIOR VENA CAVA (SVC) AND HIGH VOLTAGE (HV) IMPEDANCES ON THE RIGHT VENTRICULAR (RV) LEAD WERE HIGH. IT WAS SUSPECTED THAT THE CAUSE OF THE HIGH IMPEDANCES WAS A SET SCREW ISSUE, AND AS SUCH, THE LEAD CONNECTION WAS RETIGHTENED AND THE ISSUE APPEARS TO HAVE BEEN RESOLVED. THE LEAD AND DEVICE REMAIN 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
    56662 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Hospitalization| R (B)(4) IMPLANTABLE DEFIBRILLATOR