BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3990062 · Received August 7, 2014

    Report

    Report Number
    2649622-2014-08845
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    August 13, 2013
    Report Date
    June 19, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: D314TRG ICD IMPLANTED 2012-(B)(6); 693558 LEAD IMPLANTED 2012-(B)(6); 419478 LEAD IMPLANTED 2012-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS EXHIBITING T-WAVE OVERSENSING (TWOS), LEADING TO AN INAPPROPRIATE SHOCK TO THE PATIENT. THE PATIENT WAS HOSPITALIZED. THE LEAD SENSITIVITY WAS ADJUSTED AND THE VENTRICULAR BLANKING PERIOD WAS LENGTHENED. THE LEAD REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE PRODUCT SURVEILLANCE REGISTRY STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462662 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693558

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR Hospitalization| R 5076-52 LEAD