Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC XOMED INC. NIM® PROBE; STIMULATOR, NERVE
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC XOMED INC. NIM® PROBE; STIMULATOR, NERVE Back to Search Results
Model Number 8225101
Medical Device Problem Code Device Sensing Problem (2917)
Health Effect - Clinical Codes No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event 06/13/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device has not yet been returned for evaluation.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
The customer reported when using the probe it was working intermittently.They had to disconnect and reconnect to make it work.
 
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NIM® PROBE
Common Device Name
STIMULATOR, NERVE
Manufacturer (Section D)
MEDTRONIC XOMED INC.
6743 southpoint dr n
jacksonville FL 32216
MDR Report Key7678675
Report Number1045254-2018-00286
Device Sequence Number14114450
Product Code ETN
UDI-Device Identifier00681490176682
UDI-Public00681490176682
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
K934426
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Other
Type of Report Initial,Followup
Report Date (Section B) 10/03/2018
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 Expiration Date02/21/2026
Device Model Number8225101
Device Catalogue Number8225101
Device Lot Number0214970709
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/19/2018
Supplement Date Received by Manufacturer08/08/2018
Initial Report FDA Received Date07/11/2018
Supplement Report FDA Received Date10/03/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-