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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM® 3.0 INTERFACE - PULSE; STIMULATOR, NERVE
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MEDTRONIC XOMED INC. NIM® 3.0 INTERFACE - PULSE; STIMULATOR, NERVE Back to Search Results
Model Number 8253210
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 connectors were loose on pcb.The assembly clip and parts/components were bent.Assembly clips and wave washers worn out.Fuse decal missing.Assembly clips have been replaced.Fuse decal has been replaced.The unit has been successfully tested according 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 interface was not working.There was no patient impact.
 
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Brand Name
NIM® 3.0 INTERFACE - PULSE
Common Device Name
STIMULATOR, NERVE
Manufacturer (Section D)
MEDTRONIC XOMED INC.
6743 southpoint dr n
jacksonville FL 32216
MDR Report Key9369215
Report Number1045254-2019-00625
Device Sequence Number2708868
Product Code ETN
UDI-Device Identifier00643169283282
UDI-Public00643169283282
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
K083124
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) 11/25/2019
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 Number8253210
Device Catalogue Number8253210
Device Lot Number209731315
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/11/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/30/2019
Initial Report FDA Received Date11/25/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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