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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM-ECLIPSE® PREAMPLIFIER; STIMULATOR, ELECTRICAL, EVOKED RESPONSE
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MEDTRONIC XOMED INC. NIM-ECLIPSE® PREAMPLIFIER; STIMULATOR, ELECTRICAL, EVOKED RESPONSE Back to Search Results
Model Number DAQ916
Medical Device Problem Code Use of Device Problem (1670)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Analysis found that the rear housing panel, top and bottom housing are cracked.The analog front end pcb, bottom pwa and analog ch pcba are defective (failure during the 32 traces tests).The parts have been replaced.The parts have been cleaned.The device was tested and passed all 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 preamplifier was not working properly.There was no patient impact.
 
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Brand Name
NIM-ECLIPSE® PREAMPLIFIER
Common Device Name
STIMULATOR, ELECTRICAL, EVOKED RESPONSE
Manufacturer (Section D)
MEDTRONIC XOMED INC.
6743 southpoint dr n
jacksonville FL 32216
MDR Report Key9521048
Report Number1045254-2019-00696
Device Sequence Number16913965
Product Code GWF
UDI-Device Identifier00613994910950
UDI-Public00613994910950
Combination Product (Y/N)N
Initial Reporter CountryGM
PMA/510(K) Number
K050798
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 12/26/2019
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 NumberDAQ916
Device Catalogue NumberDAQ916
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/31/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/03/2019
Initial Report FDA Received Date12/26/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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