BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC MAXIMO

    MDR report key: 3992147 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14899
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    July 7, 2010
    Report Date
    June 4, 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
    MD, US
    Reporter Occupation
    OTHER

    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 MEDICAL PRODUCTS: 419378 LEAD, IMPLANTED: (B)(6) 2003; 5076-52 LEAD, IMPLANTED: (B)(6) 2002. (B)(4). EVALUATION SUMMARY: THE DEVICE MET 98.77% OF EXPECTED LONGEVITY. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE DEVICE WAS "DEFECTIVE." THE DEVICE HAD PREVIOUSLY BEEN RETURNED TO MEDTRONIC, WITH PAPERWORK INDICATING IT WAS REPLACED DUE TO ERI (ELECTIVE REPLACEMENT INDICATOR). FOLLOW-UP WAS NOT ATTEMPTED DUE TO THE TIME SINCE EXPLANT AND PATIENT NOTING AN APPARENT SWITCH IN PHYSICIAN OFFICE. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    470445 INSYNC MAXIMO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7304

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Hospitalization| R 694765 LEAD