BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 3153772 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06210
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 12, 2013
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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: 4196 IMPLANTABLE PACING LEAD 2010-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT T WAVE OVERSENSING WAS OBSERVED ON THE VENTRICULAR LEAD VIA THE REMOTE DATA TRANSMISSION. THE LEAD SENSITIVITY WAS REPROGRAMMED AND REMAINS IN USE. THE PATIENT IS ENROLLED IN THE SYSTEM LONGEVITY STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255417 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 693565

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention D284TRK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (IC