BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVISA DR MRI SURESCAN

    MDR report key: 3992167 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01994
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 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 MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES; HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S. THIS EVENT OCCURRED OUTSIDE THE US AND PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCTS: (B)(4) IMPLANTED: 2014 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NIGHT AFTER AN IMPLANT OF AN IMPLANTABLE PULSE GENERATOR (IPG), ONE BEAT OVERSENSING WAS OBSERVED. THE LEADS' THRESHOLDS OR IMPEDANCES WERE IN RANGE, AND AN X-RAY DID NOT LOCATE ANY ANOMALIES. THE PHYSICIAN ADJUSTED THE SENSITIVITY AND WILL MONITOR THE PATIENT. THE DEVICE REMAINS IN USE AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468937 ADVISA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND A3DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00085 YR Required Intervention (B)(4) LEAD