BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 3863149 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06558
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 11, 2014
    Report Date
    March 13, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 THE THRESHOLDS INCREASED ON THE RIGHT VENTRICULAR (RV) LEAD. THE PATIENT HEARD LEAD INTEGRITY ALERT (LIA) FOR TWO SEPARATE EPISODES OF RV OVERSENSING. THE PHYSICIAN ELECTED TO PLACE RV PACE/SENSE (P/S) LEAD, KEEPING THE HIGH VOLTAGE COILS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340638 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 00036 YR Hospitalization| R D314VRG ICD