BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO II DR

    MDR report key: 3990045 · Received August 7, 2014

    Report

    Report Number
    9614453-2014-01825
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 24, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    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 DEVICE DELIVERED POTENTIALLY INAPPROPRIATE ANTITACHYCARDIA PACING (ATP) THERAPY FOR A SUPRA VENTRICULAR TACHYCARDIA (SVT) RHYTHM. 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
    462845 MAXIMO II DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND D284DRG

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR