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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 945DAQ916
Medical Device Problem Code Use of Device Problem (1670)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 05/05/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Analysis found failure of components.Unit arrived with cracked back enclosure and unit failed calibration test.Replaced defective front board, enclosure with front and back panel.Then run-in test for 8 hours.The item was tested and passed all manufacturing specifications.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
The healthcare provider (hcp) reported that the device was not functioning correctly.There was no known 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 Key10095440
Report Number1045254-2020-00264
Device Sequence Number14337560
Product Code GWF
UDI-Device Identifier00643169071933
UDI-Public00643169071933
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K050798
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) 05/28/2020
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 Number945DAQ916
Device Catalogue Number945DAQ916
Device Lot Number206769536
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/08/2020
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/05/2020
Initial Report FDA Received Date05/28/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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