BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 4831227 · Received June 10, 2015

    Report

    Report Number
    2649622-2015-05665
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    April 30, 2015
    Report Date
    April 30, 2015
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NOISE ON THE PACE/SENSE PORTION OF THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD WAS INACTIVATED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED BY THE CLINICIAN THAT REPROGRAMMING WAS PERFORMED AND THE LEAD REMAINS IN USE WITH CONTINUED MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379535 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| R CD1357-40C ICD