BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO VR

    MDR report key: 3152000 · Received June 7, 2013

    Report

    Report Number
    3004209178-2013-08797
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    August 16, 2006
    Report Date
    March 5, 2013
    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

    THIS EVENT OCCURRED OUTSIDE THE U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED BUT WAS NOT ANALYZED AS IT MET EXPECTED LONGEVITY. HOWEVER, WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. THE DAILY BATTERY VOLTAGE TREND DATA SHOWS MINIMUM BATTER=2.93 TO 2.62 VOLTS MINIMUM BETWEEN (B)(4) 2012 AND (B)(4) 2013 IS JUST BEFORE DEVICE ALERT FOR RECOMMENDED REPLACEMENT TIME (RRT)<(><<)>= 2.62 VOLTS. THERE WAS ONE POWER ON RESET (POR) FOR WRITE TO LOCKED RAM ON 16-AUG-2006. THERE WAS ONE PATIENT ALERT FOR THE POR ON 16-AUG-2006. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 6949, IMPLANTABLE TACHY LEAD. (B)(6) 2006. (B)(4). -

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO NORMAL BATTERY DEPLETION AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER'S ANALYSIS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252481 MAXIMO VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7232CX

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention