BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENSURA DR MRI SURESCAN

    MDR report key: 6162562 · Received December 9, 2016

    Report

    Report Number
    9614453-2016-07195
    Event Type
    Malfunction
    Date Received
    December 9, 2016
    Date of Event
    September 16, 2016
    Report Date
    September 26, 2016
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THE RETURNED DEVICE INDICATED A LOOSE/DETACHED SET SCREW. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE LEAD WAS CONNECTED TO THE IMPLANTABLE PULSE GENERATOR (IPG). THE LEAD HAD TO BE REPOSITIONED SO IT WAS DISCONNECTED FROM THE IPG. WHEN THE PHYSICIAN TRIED TO RECONNECT THE LEAD THEY WERE NOT ABLE TO SET THE SCREW DOWN. ANOTHER DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    809166 ENSURA DR MRI SURESCAN PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND EN1DR01

    Patients

    Seq Age Sex Outcome Treatment
    1