BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC MAXIMO

    MDR report key: 2955345 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02089
    Event Type
    Injury
    Date Received
    February 11, 2013
    Report Date
    December 4, 2012
    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
    TX, 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 IMPLANTABLE PACING LEAD (B)(6) 2006; 69474 IMPLANTABLE TACHY LEAD (B)(6) 2006. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY THE DEVICE WAS RETURNED AND ANALYZED. THE DEVICE LOST TELEMETRY AND FUNCTION DUE TO BATTERY DEPLETION. THE CAUSE OF THE DEPLETION CANNOT BE DETERMINED. THE DEVICE WAS FULLY FUNCTIONAL AND OPERATED UNDER NORMAL CURRENT DRAIN WHEN POWERED WITH AN EXTERNAL SUPPLY. THE RESIDUAL VOLTAGE AND IMPEDANCE INDICATES THAT THE BATTERY WAS NOT INTERNALLY SHORTED SINCE NO SAVE TO DISK DATA COULD BE RETRIEVED FROM THE DEVICE AND NO OTHER DATA WAS PROVIDED FROM THE FIELD THERE IS NO WAY TO CONFIRM THIS RESULT. THE RESULT OF ANALYSIS IS INCONCLUSIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)  COULD NOT BE INTERROGATED. IT WAS FOUND THAT THE I CD WAS AT ELECTIVE REPLACEMENT INDICATOR (ERI). THE ICD 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
    59141 INSYNC MAXIMO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7304

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Hospitalization| R 4193 IMPLANTABLE PACING LEAD