BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO

    MDR report key: 3861271 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07334
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    April 25, 2014
    Report Date
    April 25, 2014
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 DURING A ROUTINE DEVICE CHANGEOUT PROCEDURE THE PHYSICIAN OBSERVED WHAT APPEARED TO BE AN INSULATION BREACH ON THE EXISTING RIGHT VENTRICULAR (RV) LEAD. NO PERFORMANCE ISSUES WERE NOTED FOR THE LEAD HOWEVER, THE PHYSICIAN ELECTED TO CAP AND REPLACE THE LEAD AT THAT TIME. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339842 SPRINT QUATTRO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6944-65

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Required Intervention D154VWC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR