BEUDAMED
    FDA Adverse Event Death Summary report: N

    SOPHONO® IMPLANT

    MDR report key: 5997900 · Received October 4, 2016

    Report

    Report Number
    1045254-2016-00324
    Event Type
    Death
    Date Received
    October 4, 2016
    Report Date
    March 16, 2016
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    LXB
    PMA / PMN Number
    K132189
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION: ANALYSIS RESULTS NOT AVAILABLE; DEVICE NOT RETURNED FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 1

    DATE OF THIS REPORT: 03/16/2016. DATE MANUFACTURER RECEIVED: 01/05/2017. 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

    DURING A COMMUNICATION IN JUNE 2016 BETWEEN A MEDTRONIC INTERNATIONAL MEDICAL AFFAIRS STAFF MEMBER AND THE PERFORMING SURGEON, ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME WAS OBTAINED. IT WAS REPORTED TO SOPHONO THAT A PATIENT WHO WAS ALREADY USING AN IMPLANT SUCCESSFULLY ON THE RIGHT SIDE SINCE (B)(6) 2013, ELECTED TO RECEIVE AN ADDITIONAL IMPLANT ON THE LEFT SIDE IN (B)(6) 2014. THE SURGEON REPORTED THAT BOTH PROCEDURES WERE ROUTINE CASES PERFORMED UNDER GENERAL ANESTHESIA. APPROXIMATELY 15 - 20 MINUTES AFTER SURGERY FOR THE SECOND IMPLANT, WHEN THE PATIENT WAS IN THE RECOVERY ROOM, HE STARTED TO COMPLAIN OF A HEADACHE, COLLAPSED AND LOST CONSCIOUSNESS. THE PATIENT WAS INTUBATED AND A CT SCAN CONFIRMED A LARGE INTRACRANIAL BLEED (SUB-ARACHNOID HEMATOMA) ON THE LEFT SIDE. THE PATIENT WAS THEN TRANSFERRED TO A NEUROSURGICAL HDU UNIT AT ANOTHER FACILITY, STILL UNRESPONSIVE. THE ADDITIONAL INFORMATION RECEIVED IN JUNE OF 2016 INDICATED THAT THE PATIENT ULTIMATELY EXPIRED. THE PERFORMING SURGEON CONFIRMED THERE WAS NO ALLEGATION AGAINST THE DEVICE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647065 SOPHONO® IMPLANT HEARING AID, BONE CONDUCTION LXB MEDTRONIC XOMED, INC. S0521-02 P285462-00

    Patients

    Seq Age Sex Outcome Treatment
    1 Death