BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO VR

    MDR report key: 3990016 · Received August 7, 2014

    Report

    Report Number
    9614453-2014-01824
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 24, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE ACTUAL PRODUCT WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA WAS COLLECTED FROM THE DEVICE AND WAS ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED A POWER ON RESET OCCURRED. POR OCCURRED ON (B)(6) 2014. THE USE BEFORE DATE ON THE IMPLANT WAS 14.03.2007 AND THE DEVICE WAS IMPLANTED ON (B)(6) 2010.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POWER ON RESET OCCURRED IN THE DEVICE REQUIRING REPROGRAMMING. A COMPARISON OF THE USE BEFORE DATE FIELD AND IMPLANT DATE FOUND THE DEVICE WAS IMPLANTED AFTER THE USE BEFORE DATE. THE DEVICE 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
    465093 MAXIMO VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND 7232CX

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention