BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO II VR

    MDR report key: 2953122 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00196
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 28, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND OVERSENSING OCCURRED. ONE VENTRICULAR FIBRILLATION (VF) EPISODE OF 210 MS AVERAGE VENTRICULAR CYCLE OCCURRED ON (B)(4)-2010 AT 13:14:02.

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US 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 THE DOCTOR SUSPECTED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPIES. THE PATIENT WILL BE CHECKED TO DETERMINE WHETHER REPROGRAMMING WILL BE PERFORMED. THE DEVICE AND RIGHT VENTRICULAR (RV) LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57241 MAXIMO II VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D284VRC

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R 6947 IMPLANTABLE TACHY LEAD