BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSYNC MAXIMO

    MDR report key: 3862043 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11120
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    February 21, 2014
    Report Date
    March 6, 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
    DC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. 694765 LEAD IMPLANTED: (B)(6) 2002; 419378 LEAD IMPLANTED: (B)(6) 2005. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY SHOWED THE BATTERY INDICATOR SIGNIFYING THAT IT THE TIME IS APPROACHING FOR DEVICE REPLACEMENT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ELECTIVE REPLACEMENT INDICATOR (ERI) STATUS HAD NOT BEEN TRIGGERED FOR THE DEVICE, DESPITE THE BATTERY VOLTAGE HAVING REACHED 2.62 VOLTS ON (B)(6) 2014 PER THE CARELINK QUICKLOOK REPORT. THE REQUIREMENT FOR 3 CONSECUTIVE NIGHTS OF A BATTERY VOLTAGE OF LESS THAN OR EQUAL TO 2.62 VOLTS WAS DISCUSSED. THE DEVICE WAS EXPLANTED AND REPLACED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342216 INSYNC MAXIMO DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7304

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization| R 1488T LEAD