BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO VR

    MDR report key: 8282602 · Received January 28, 2019

    Report

    Report Number
    3004209178-2019-01869
    Event Type
    Injury
    Date Received
    January 28, 2019
    Date of Event
    December 18, 2018
    Report Date
    January 30, 2019
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED A POWER ON RESET OCCURRED. ANALYSIS OF THE DEVICE MEMORY SHOWED THE BATTERY IS A APPROACHING THE INDICATOR SIGNIFYING THE TIME FOR DEVICE REPLACEMENT. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENTS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD TRIGGERED A POWER ON RESET (POR). IT WAS NOTED THAT THE PATIENT¿S DEVICE IS NEARING RECOMMENDED REPLACEMENT TIME (RRT) AND THE PATIENT IS SENDING MONTHLY REMOTE MONITOR REPORTS. THE PATIENT HAS NO COMPLAINTS AND DENIES ACTIVITY THAT MAY HAVE CAUSED A DEVICE RESET. THE POR WAS CLEARED, AND THE DEVICE CURRENTLY REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75127 MAXIMO VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7232CX

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention 694765, LEAD