BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC SENTRY

    MDR report key: 2938422 · Received January 31, 2013

    Report

    Report Number
    3004209178-2013-01206
    Event Type
    Injury
    Date Received
    January 31, 2013
    Report Date
    August 16, 2010
    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
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THESE EVENTS WERE REPORTED TO FDA ON JANUARY 31, 2013 WITHIN A RETROSPECTIVE SUMMARY REPORT. THE FDA APPROVAL NUMBER FOR THIS SUMMARY REPORT IS (B)(4). THE TOTAL NUMBER OF EVENTS BEING SUMMARIZED FOR PRODUCT CODE NIK IS 994, INCLUDIG THE 3500A EVENT AND EVENTS DETAILED IN THE XLS. THIS RETROSPECTIVE REVIEW WAS PERFORMED FOLLOWING OUR FIRM'S CHANGE IN MEDICAL DEVICE REPORTING CRITERIA. THESE REPORTS REPRESENT EVENTS WITH ALERT DATES IN THE TWO YEARS PRIOR TO THAT CHANGE IN REPORTING CRITERIA. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 419488 IMPLANTABLE PACING LEAD: (B)(6) 2006. 407645 IMPLANTABLE PACING LEAD: (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE LASTED LESS THAN 5 YEARS. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42433 INSYNC SENTRY DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7299

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| R 694958 IMPLANTABLE TACHY LEAD| 694958 IMPLANTABLE TACHY LEAD