BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO DR

    MDR report key: 2951579 · Received February 9, 2013

    Report

    Report Number
    9614453-2013-00048
    Event Type
    Malfunction
    Date Received
    February 9, 2013
    Date of Event
    October 12, 2012
    Report Date
    November 2, 2012
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME/SIMILAR MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. 4097 IMPLANTABLE PACING LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DURING A DEVICE REPLACEMENT PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD COULD NOT BE SEPARATED FROM THE DEVICE CONNECTOR. THE DEVICE AND LEAD WERE EXPLANTED AND REPLACED. THE PATIENT IS A PARTICIPANT IN THE PANAROMA I STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56250 MAXIMO DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS IPG MFG SWITZERLAND 7278

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Required Intervention 6947 IMPLANTABLE TACHY LEAD