BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 7093745 · Received December 7, 2017

    Report

    Report Number
    2182208-2017-02088
    Event Type
    Injury
    Date Received
    December 7, 2017
    Date of Event
    September 1, 2017
    Report Date
    December 7, 2017
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL NUMBERS. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. THE GENDER OF THE BASELINE CHARACTERISTICS IS MALE AND THE BASELINE AGE IS 54 YEARS OLD. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: SUN Y-X, GAO J, JIANG C-Y, XUE Y-M, XU Y-Z, LIU G, GUO J-H, SHENG X, YE Y, HE H, ZHAO Y-T, BARAJAS-MARTINEZ H, FU G-S AND HU D. ¿T WAVE SAFETY MARGIN DURING THE PROCESS OF ICD IMPLANTATION AS A NOVEL PREDICTOR OF T WAVE OVERSENSING.¿ FRONT. PHYSIOL. 2017: 8:659. DOI: 10.3389/FPHYS.2017.00659. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEMS. MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE SERIAL NUMBERS WITH THE AVAILABLE INFORMATION PROVIDED. THE ARTICLE INDICATED THAT THERE WAS T-WAVE OVERSENSING (TWOS) NOTED DURING EX VIVO TESTING. THERE WAS ALSO ONE PATIENT WHO HAD TWOS DURING THE FOLLOW UP PERIOD. THE STATUS/LOCATION OF THE DEVICE/LEAD IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    872855 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)