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® 3.0 INTERFACE; 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® 3.0 INTERFACE; STIMULATOR, NERVE Back to Search Results
Model Number 8253200RF
Medical Device Problem Code Use of Device Problem (1670)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Analysis found that the customer's complaint was confirmed.The device came in with broken cable clips and broken clamshell pawl.P/i board was replaced due to stim 1 failure.All broken parts were replaced.The device was cleaned, repaired, 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 device was not working properly.There was no known patient impact.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
NIM® 3.0 INTERFACE
Common Device Name
STIMULATOR, NERVE
Manufacturer (Section D)
MEDTRONIC XOMED INC.
6743 southpoint dr n
jacksonville FL 32216
MDR Report Key8086134
Report Number1045254-2018-00608
Device Sequence Number16577926
Product Code ETN
UDI-Device Identifier00643169782501
UDI-Public00643169782501
Combination Product (Y/N)N
Initial Reporter StateNY
Initial Reporter CountryUS
PMA/510(K) Number
K083124
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 11/19/2018
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 Model Number8253200RF
Device Catalogue Number8253200RF
Device Lot Number206844804
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/23/2018
Initial Report FDA Received Date11/19/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
-
-