BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO VR

    MDR report key: 3990783 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01757
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 21, 2014
    Report Date
    June 22, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE A SIMILAR 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 PATIENT HAD AN EPISODE OF VENTRICULAR FIBRILLATION (VF) AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DID NOT PROVIDE THERAPY. THE PATIENT WAS TAKEN TO THE HOSPITAL AND RECEIVED EXTERNAL DEFIBRILLATION. DEVICE INTERROGATION INDICATED THERE WERE THREE OTHER EVENTS THAT WERE NOT TREATED AND THE ICD HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469561 MAXIMO VR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND 7232CX

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Hospitalization| L| R