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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM® 3.0 INTERFACE; STIMULATOR, NERVE
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MEDTRONIC XOMED INC. NIM® 3.0 INTERFACE; STIMULATOR, NERVE Back to Search Results
Model Number 8253200RF
Medical Device Problem Code Use of Device Problem (1670)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Analysis found that the reported complaint of not functioning could not be duplicated.The device was disassembled, cleaned, replaced worn wave washers, reassembled, tested and passed in accordance with manufacturing specifications.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
A health care provider (hcp) reported that the patient interface was not functioning.There was no known patient impact reported.
 
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Brand Name
NIM® 3.0 INTERFACE
Common Device Name
STIMULATOR, NERVE
Manufacturer (Section D)
MEDTRONIC XOMED INC.
6743 southpoint dr n
jacksonville FL 32216
MDR Report Key8703345
Report Number1045254-2019-00293
Device Sequence Number16642464
Product Code ETN
UDI-Device Identifier00643169782501
UDI-Public00643169782501
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K083124
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 06/17/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number8253200RF
Device Catalogue Number8253200RF
Device Lot Number208128773
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/30/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/22/2019
Initial Report FDA Received Date06/17/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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