BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 4162445 · Received October 10, 2014

    Report

    Report Number
    2649622-2014-12769
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 24, 2014
    Report Date
    August 24, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 LIA (LEAD INTEGRITY ALERT) TRIGGERED DUE TO NST (NON-SUSTAINED TACHYCARDIA) EPISODES AND ELEVATED SIC (SENSING INTEGRITY COUNTER). THE REPORTER NOTED THAT THE NST EPISODES HE HAD REVIEWED SO FAR LOOKED LIKE VT (VENTRICULAR TACHYCARDIA), BUT HE HAD NOT VIEWED ALL OF THEM YET. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT SENSITIVITY WAS REPROGRAMMED, WHICH RESOLVED/REMOVED THE SOURCE OF THE SHORT INTERVALS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639701 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention