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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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event 11/18/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Analysis found that the unit was received in good cosmetic condition.The customer's complaint could not be confirmed, no deviations have been found.The unit has been successfully tested according to service repair instructions.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
A healthcare professional (hcp) reported that the preamp was not working.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 Key11011107
Report Number1045254-2020-00615
Device Sequence Number4496830
Product Code GWF
UDI-Device Identifier00613994910950
UDI-Public00613994910950
Combination Product (Y/N)N
Initial Reporter CountrySP
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) 12/15/2020
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
Device Lot Number206845036
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/25/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/18/2020
Initial Report FDA Received Date12/15/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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