BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVISA DR MRI SURESCAN

    MDR report key: 2964351 · Received February 15, 2013

    Report

    Report Number
    9614453-2013-00326
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    November 29, 2012
    Report Date
    November 29, 2012
    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
    PHYSICIAN

    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. THE EVENT IS BEING REPORTED DUE TO AN ALLEGED MALFUNCTION. PRODUCT EVENT SUMMARY : THE DEVICE AND FULL RIGHT VENTRICULAR LEAD WERE RETURNED AND ANALYZED; ANALYSIS REVEALED NO ANOMALIES. THERE WAS BLOOD IN/ON THE HELIX MECHANISM OF THE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PACING SYSTEM WAS IMPLANTED IN THE PACEMAKER-DEPENDENT PATIENT AND WHEN THE TEMPORARY PACEMAKER WAS DISCONNECTED AND THE NEW SYSTEM APPLIED, THE DEVICE WAS NOT PACING AND THE PATIENT'S HEART RATE WAS VERY SLOW. THE ISSUE COULD NOT BE REPEATED SO THE SYSTEM REMAINED IN USE. THE FOLLOWING DAY, THE RIGHT VENTRICULAR LEAD HAD LOW THRESHOLD, INTERMITTENT PACING, LOW R WAVE SENSING, AND THE LEAD WAS UNDERSENSING. THE DEVICE AND RIGHT VENTRICULAR LEAD WERE EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66778 ADVISA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND A3DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Hospitalization| L| R (B)(4) X2 IMPLANTABLE PACING LEADS