BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAINFRAME 8252401IP NEURO 2.0 W/INCRE

    MDR report key: 2043984 · Received April 7, 2011

    Report

    Report Number
    1045254-2011-00014
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 22, 2011
    Manufacturer
    MEDTRONIC XOMED, INC.
    Product Code
    ETN
    PMA / PMN Number
    K024316
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    "SURGEON #2 TOLD US THAT HE 'FEELS' THE PATIENT WAS INJURED, BECAUSE OF THIS NIM. HE SAID HE HAS PROBLEMS WITH THE OLD NIM'S OF THE SAME MODEL. HE SAID HE HAD JUST HAD A PROBLEM THE DAY BEFORE AT A NEIGHBORING (B)(6) HOSPITAL WITH THE SAME MODEL OF THE NIM'S . HE FEELS ALL THE OLDER NIM'S ARE HAVING ISSUES. HE SAID HE REPORTED MULTIPLE CONCERNS FROM THREE OTHER HOSPITALS TO MEDTRONIC REPRESENTATIVE. THE SURGEON SAID THAT ALL THE PROBLEMS WERE WITH THE OLD EQUIPMENT MODELS, AND THE NEWER MODEL IS MORE 'SENSITIVE.'" A NEW COMPLAINT REPORT HAS BEEN ENTERED INTO MEDTRONIC XOMED INC. COMPLAINT DATABASE FOR THIS NEW PRODUCT EVENT INFORMATION RE: 'A NEIGHBORING (B)(6) HOSPITAL'. "PER THE NEUROSURGEON IN DISCHARGE SUMMARY, THE PATIENT'S DISCHARGE CONDITION HAS IMPROVED. THERE IS NO WAY TO DEFINITELY DETERMINE IF THE PATIENT IS IMPACTED." "WHAT WAS THE ORIGINAL INTENDED PROCEDURE?" THE PATIENT WAS TO UNDERGO A TWO PART SURGERY. SURGERY ONE WAS DECOMPRESSION OF THE TUMOR BY THE NEUROSURGEON AND A RIGHT TRANSPETROSAL APPROACH AND PLACEMENT OF AN OSSEO INTEGRATED IMPLANT FOR BONE ANCHORED HEARING AID BY DEFINITIVE TUMOR RESECTION BY THE NEUROSURGEON. OTHER THERAPIES IN USE ON THE PATIENT ARE NOT KNOWN. OTHER DEVICES IN USE ON THE PATIENT: HISTORY THAT MAY HAVE CONTRIBUTED TO THE EVENT: PATIENT HAD A VERY LARGE 4-5 CM RIGHT SIDE POSTERIOR FOSSA PETROCLIVAL MENINGIOMA WITH SIGNIFICANT MASS EFFECT AND SHIFT ON THE BRAINSTEM. PRE-SURGICAL NEUROSURGICAL CRANIAL NERVE EXAMINATION STATED A LITTLE BIT OF RIGHT GAZE NYSTAGMUS, TRIGEMINAL FUNCTION SHOWED A HINT OF WEAKNESS IN THE RIGHT NASOLABIAL FOLD, HEARING WAS SIGNIFICANTLY DELAYED AND DIMINISHED, ABSENT GAG RESPONSE, LEFT PRONATOR DRIFT, MILD LEFT HEMIPARESIS." THE CUSTOMER REQUESTED A RETURN AUTHORIZATION NUMBER FROM THE MEDTRONIC XOMED SERVICE AND REPAIR DEPARTMENT ON (B)(6), 2011. AT THAT TIME, THE CUSTOMER SUPPLIED THE DEVICE SERIAL NUMBER AS (B)(4)."

    Additional Manufacturer Narrative · 1

    THE REPORTING FACILITY HAS TWO NIM NEURO 2.0 SYSTEMS, AND DOES NOT KNOW WHICH SYSTEM WAS INVOLVED IN THE REPORTED INCIDENT. THE TWO SERIAL NUMBERS ARE (B)(4) (LOT 47939700, MANUFACTURED DECEMBER 2006), AND (B)(4) (LOT 56025300, MANUFACTURED MAY 2008). ANY MISSING OR INCOMPLETE DATA ON FORM 3500A IS THE RESULT OF INFORMATION NOT BEING PROVIDED OR RELEASED BY THE REPORTER DESPITE MULTIPLE ATTEMPTS TO OBTAIN THE REQUIRED INFORMATION. ATTEMPTS TO OBTAIN THE INFORMATION ARE DOCUMENTED IN THE COMPLAINT FILE. THE DEVICE WAS USED FOR TREATMENT AND NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE DOCTOR REPORTED THAT THE NIM "DID NOT GO OFF," AND THE PATIENT SUSTAINED TEMPORARY FACIAL NERVE PARALYSIS. AS OF THIS DATE, THE FACILITY IS NOT RELEASING THE NIM NEURO 2.0 SYSTEM DUE TO A POSSIBLE LEGAL ISSUE. THE CONTACT AT THE FACILITY REPORTED THAT THE PATIENT HAS NO PERMANENT INJURY. CURRENTLY, THE FACILITY IS NOT RELEASING THE NIM 2 SYSTEMS DUE TO POSSIBLE LEGAL REASONS. THE FACILITY CONTACT DID REPORT THE PATIENT DID NOT HAVE ANY PERMANENT INJURY.

    Description of Event or Problem · 1

    MEDWATCH (B)(4) WAS RECEIVED FROM THE CUSTOMER ON (B)(6) 2011. THE CUSTOMER REPORTS: "AFTER THE FIRST SURGERY , SURGEON #2 MADE A COMPLAINT TO THE OPERATING ROOM MANAGER STATING THAT HE WANTED THE NIM'S CHECKED OUT SINCE THE PROBE FUNCTION WAS QUESTIONABLE DURING THE PROCEDURE, HE STATED THE PATIENT COULD HAVE NERVE DAMAGE, BUT THAT THE PATIENT HAD PROMISING SIGNS OF EYE BLINKING. AT THAT TIME IT COULD NOT BE IDENTIFIED WHICH OF THE TWO HOSPITAL OWNED NIM'S WAS USED. BOTH NIM'S WERE SENT TO OUR BIOMED DEPARTMENT , WHO REPORTED , 'SETUP AND TESTED BOTH UNITS PER MANUFACTURER'S CHECKLIST. ALL TEST PASSED, NO PROBLEMS INDICATED.' NEUROSURGEON ASSESSMENT AFTER SURGERY #1 INDICATED RIGHT FACIAL WEAKNESS. SURGEON #2 NOTED COMPLETE EYE CLOSURE WITH EFFORT, NO NYST AGMUS IN PRIMARY, OR LATERAL GAZE. FACIAL NERVE HAD A GOOD PROGNOSIS, WE MADE A DECISION TO KEEP BOTH NIM'S OUT OF DEVICE UNTIL WE COULD DETERMINE IF THE PATIENT WAS EFFECTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAINFRAME 8252401IP NEURO 2.0 W/INCRE ETN - STIMULATOR, NERVE ETN MEDTRONIC XOMED, INC. 8252401IP 47939700

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR