BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVISA DR MRI SURESCAN

    MDR report key: 3993403 · Received August 8, 2014

    Report

    Report Number
    9614453-2014-01906
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 19, 2014
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, WHILE DISCONNECTING THE ATRIAL AND VENTRICULAR LEADS FROM THE IPG SEVERAL TURNS OF THE SETSCREW WAS MADE. THEN DURING ATTEMPT TO RECONNECT THE ATRIAL LEAD IT WAS NOT POSSIBLE TO LOCATE THE SETSCREW IN THE IPG HEADER TO SECURE THE LEAD. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO LOCATE THE SETSCREW IN THE IPG HEADER. THE IPG WAS REMOVED AND EXCHANGED FOR ANOTHER DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469304 ADVISA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND A3DR01

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR