BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NIM® 3.0 MAINFRAME

    MDR report key: 5290301 · Received December 11, 2015

    Report

    Report Number
    1045254-2015-00424
    Event Type
    Injury
    Date Received
    December 11, 2015
    Date of Event
    November 6, 2015
    Report Date
    November 16, 2015
    Manufacturer
    MEDTRONIC XOMED INC.
    Product Code
    ETN
    PMA / PMN Number
    K083124
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: (1) RESP 3.0 PATIENT INTFC REFURB (8253200RF); SN: (B)(4); DATE OF MANUFACTURE: MARCH 22, 2010; RETURNED TO MEDTRONIC: NOVEMBER 6, 2015; (B)(4). (B)(4). IN RESPONSE TO MEDTRONIC¿S REQUEST FOR DEVICE RETURN, THE DEVICES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION AND REPAIR (DETAILED AS FOLLOWS): 8253001 ¿ ANALYSIS WAS NOT ABLE TO CONFIRM OR DUPLICATE THE ALLEGED COMPLAINT, FINDING NO FAULT OR OUT OF SPECIFICATION CONDITIONS DIRECTLY RELATED TO THE REPORTED EVENT. HOWEVER, THE SOFTWARE WAS OUTDATED. THE DEVICE WAS REPAIRED, TESTED, AND PASSED ALL MANUFACTURING SPECIFICATIONS. 8253200RF ¿ ANALYSIS WAS NOT ABLE TO CONFIRM OR DUPLICATE THE ALLEGED COMPLAINT, FINDING NO FAULT OR OUT OF SPECIFICATION CONDITIONS DIRECTLY RELATED TO THE REPORTED EVENT. HOWEVER, THE CABLE CLIPS WERE LOOSE DUE TO WORN WAVE WASHERS. THE DEVICE WAS REPAIRED, TESTED, AND PASSED ALL MANUFACTURING SPECIFICATIONS. THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(6). THE FOLLOWING INFORMATION WAS RECEIVED ON DECEMBER 21, 2015. TYPE OF PROCEDURE BEING PERFORMED: PAROTIDECTOMY ¿ PATIENT STATUS AS A RESULT OF THE EVENT: ¿RESCHEDULED, THERE WAS NO HARM TO PATIENT¿ THE CASE WAS CANCELLED AND RESCHEDULED ONCE THEIR DEVICE WAS REPAIRED. (B)(6). INITIAL REPORTER ALSO SENT REPORT TO FDA:

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "SOUNDING OFF" WAS " INTERMITTENT" WHILE USING THE NIM RESPONSE 3.0 SYSTEM " WHEN THE LEADS WERE PLACED UNDER THE PATIENTS SKIN, PRIOR TO INCISION." AS A RESULT, THE SURGEON WAS NOT "COMFORTABLE" AND CANCELLED THE CASE DUE TO "THE WAY IT WAS NOT WORKING AS IT NORMALLY SHOULD." THIS IS THE ONLY INFORMATION PROVIDED AND THERE WAS ALSO NO REPORT OF PATIENT IMPACT OR INJURY AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820222 NIM® 3.0 MAINFRAME STIMULATOR, NERVE ETN MEDTRONIC XOMED INC. 8253001 66156100

    Patients

    Seq Age Sex Outcome Treatment
    1 00023 YR Other