BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVISA DR

    MDR report key: 3153022 · Received June 8, 2013

    Report

    Report Number
    9614453-2013-01117
    Event Type
    Injury
    Date Received
    June 8, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SIMILAR TO A DEVICE MARKETED IN THE U.S. PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. (CONT.) 5086MRI IMPLANTABLE PACING LEAD IMPLANTED: 2013-(B)(6), 5086MRI IMPLANTABLE PACING LEAD IMPLANTED: 2013-(B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD DISLODGED. THE LEAD WAS REPOSITIONED AND REMAINS IN USE. ALSO, AS THE LEAD WAS CONNECTED TO THE IMPLANTABLE PULSE GENERATOR (IPG), THE IPG WAS NOT PACING AT MAX OUTPUTS. THE LEAD TESTED ACCEPTABLY THROUGH THE ANALYZER, THEREFORE THE DEVICE WAS EXPLANTED AND REPLACED WITH ANOTHER DEVICE WITH NO PROBLEMS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255242 ADVISA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND A3DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR Hospitalization| R