BEUDAMED
    FDA Adverse Event Summary report: N

    NIM

    MDR report key: 2032222 · Received March 11, 2011

    Report

    Report Number
    2032222
    Date Received
    March 11, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 11, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    ETN
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER THE FIRST SURGERY, SURGEON #2 MADE A COMPLAINT TO THE OR 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 TWO OWNED NIM'S WAS USED. BOTH NIM'S WERE SENT TO OUR BIOMED DEPARTMENT WHO REPORTED "SETUP AND TESTED BOTH UNITS PER MANUFACTURERS CHECKLIST. ALL TESTS PASSED...NO PROBLEMS INDICATED." NEUROSURGEON ASSESSMENT AFTER SURGERY #1 INDICATED RIGHT FACIAL WEAKNESS. SURGEON #2 NOTED COMPLETE EYE CLOSURE WITH EFFORT, NO NYSTAGMUS IN PRIMARY OR LATERAL GAZE. FACIAL NERVE HAD GOOD PROGNOSIS. SINCE THE COMPLAINT FROM SURGEON #2 WAS MADE, WE MADE A DECISION TO KEEP BOTH NIM'S OUT OF SERVICE UNTIL WE COULD DETERMINE IF THE PATIENT WAS AFFECTED. 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 NIMS 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 THAT OTHER HOSPITALS WERE NEEDING TO BUY THE NEWER MODEL AS THE NEW MODEL IS MORE "SENSITIVE." PER NEUROSURGEON IN DISCHARGE SUMMARY, THE PATIENT'S DISCHARGE CONDITION WAS IMPROVED. THERE IS NO WAY TO DEFINITELY DETERMINE IF THE PATIENT WAS IMPACTED.

    Description of Event or Problem · 1

    AFTER THE FIRST SURGERY, SURGEON #2 MADE A COMPLAINT TO THE OR 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 TWO OWNED NIM'S WAS USED. BOTH NIM'S WERE SENT TO OUR BIOMED DEPARTMENT WHO REPORTED "SETUP AND TESTED BOTH UNITS PER MANUFACTURERS CHECKLIST. ALL TESTS PASSED...NO PROBLEMS INDICATED." NEUROSURGEON ASSESSMENT AFTER SURGERY #1 INDICATED RIGHT FACIAL WEAKNESS. SURGEON #2 NOTED COMPLETE EYE CLOSURE WITH EFFORT, NO NYSTAGMUS IN PRIMARY OR LATERAL GAZE. FACIAL NERVE HAD GOOD PROGNOSIS. SINCE THE COMPLAINT FROM SURGEON #2 WAS MADE, WE MADE A DECISION TO KEEP BOTH NIM'S OUT OF SERVICE UNTIL WE COULD DETERMINE IF THE PATIENT WAS AFFECTED. 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 CHILDREN'S HOSPITAL WITH THE SAME MODEL OF THE NIM'S. HE FEELS ALL THE OLDER NIMS 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 THAT OTHER HOSPITALS WERE NEEDING TO BUY THE NEWER MODEL AS THE NEW MODEL IS MORE "SENSITIVE." PER NEUROSURGEON IN DISCHARGE SUMMARY, THE PATIENT'S DISCHARGE CONDITION WAS IMPROVED. THERE IS NO WAY TO DEFINITELY DETERMINE IF THE PATIENT WAS IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NIM NERVE STIMULATOR ETN MEDTRONIC NIM 2.0 *
    2 NIM NERVE STIMULATOR ETN MEDTRONIC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR