BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVISA DR MRI SURESCAN

    MDR report key: 3991054 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01732
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    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. PRODUCTS: 4074-58 LEAD 2014 (B)(6). (B)(4).

    Description of Event or Problem · 1

    THE PATIENT WAS NEWLY IMPLANTED WITH AN IMPLANTABLE PULSE GENERATOR (IPG). IT WAS REPORTED THAT A FEW DAYS POST IMPLANT THERE WAS VENTRICULAR PACING FAILURE. IT WAS ALSO REPORTED THERE WAS A SKIPPED A BEAT EVERY ONE HOUR AND 30 SECONDS. SENSITIVITIES WERE ADJUSTED AND 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
    471061 ADVISA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND A3DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R 4574-53 LEAD