BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC MAXIMO

    MDR report key: 3994019 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14552
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    March 3, 2014
    Report Date
    June 3, 2014
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY #(B)(4): THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED THE RETURNED DEVICE INDICATED THE ACTUAL LONGEVITY WAS LESS THAN 80% OF THE 99.9% PREDICTED LONGEVITY LIMIT. THERE WERE NO DETECTED PERFORMANCE ISSUES WITH THE DEVICE. IN THE ABSENCE OF THE COMPLETE PROGRAMMING HISTORY, IT IS NOT POSSIBLE TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL. THE DEVICE MET 71% OF THE EXPECTED LONGEVITY. CONCOMITANT MEDICAL PRODUCTS: 419488, LEAD, (B)(6) 2010; 407652, LEAD, (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, TESTED OUT OF SPECIFICATION AND IS BEING REPORTED BASED ON ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469374 INSYNC MAXIMO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7304

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Hospitalization| R 694765 LEAD