BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC SENTRY

    MDR report key: 3863088 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-10974
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    July 1, 2010
    Report Date
    August 19, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 : 5076 LEAD IMPLANTED (B)(6) 2006; 6949 LEAD IMPLANTED (B)(6) 2006. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED SHOCKS FROM THE DEVICE FOR ATRIAL FLUTTER WITH RAPID VENTRICULAR RATES. THE ATRIAL ARRHYTHMIAS WERE BEING MANAGED WITH MEDICATION AND AV NODE ABLATION WAS DISCUSSED. THE DEVICE REMAINED IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339421 INSYNC SENTRY DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7299

    Patients

    Seq Age Sex Outcome Treatment
    1 00094 YR Life Threatening 4537 COMPETITOR LEAD