BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO DR

    MDR report key: 2954537 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02445
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    February 12, 2008
    Report Date
    November 19, 2012
    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
    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. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. THE DEVICE MET 88% 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. PERFORMANCE DATA WERE ALSO COLLECTED FROM THE DEVICE AND ANALYZED. IT WAS DETERMINED A POWER ON RESET HAD OCCURRED ON (B)(6) 2008 DUE TO A WRITE TO LOCKEDRANDOM ACCESS MEMORY ERROR. THERE WAS A DEVICE ALERT FOR LOW BATTERY VOLTAGE. CONCOMITANT PRODUCT: 6945 IMPLANTABLE TACHY LEAD: (B)(6) 1999. (B)(4).

    Description of Event or Problem · 1

    THE DEVICE WAS EXPLANTED DUE TO NORMAL BATTERY DEPLETION. THE DEVICE WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND IT WAS DETERMINED A POWER ON RESET HAD OCCURRED PREVIOUSLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59406 MAXIMO DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7278

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention 6940 IMPLANTABLE PACING LEAD