• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY EDM LUMBAR CATHETER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

  • 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 NEUROSURGERY EDM LUMBAR CATHETER SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 46420
Device Problems Entrapment of Device (1212); Device Dislodged or Dislocated (2923)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/31/2021
Event Type  Injury  
Event Description
Patient brought to preop area prior to tevar. Preop assessment performed. Timeout performed in presence of anesthesiologists. Pt placed on asa monitors, placed in sitting position. All vss. Back prepped with chloraprep, drape placed under sterile conditions, and lumbar drain kit opened. Landmarks identified and skin localized with 2% lidocaine. 14g tuohy passed through lumbar region x1 attempt atraumatically using lor technique at the midline around l2. Continued to advance tuohy until csf flowed freely. Catheter passed through tuohy without resistance. Tuohy needle withdrawn slowly without resistance and completely removed from skin. Catheter was initially withdrawn to decrease the amount that was intrathecal, however upon light traction catheter fell out of skin. Upon inspection of the lumbar catheter, it became apparent that the remaining portion of the catheter was still in the patient. The skin was examined but there was no evidence of the catheter visible and no evidence of csf leak. The patient's vitals signs remained stable. Appropriate disclosure of circumstances was made to the patient. No parasthesia or other symptoms reported by the patient. Vascular surgeon was notified, who then immediately called neurosurgery, who ordered ap and lateral films of the lumbar spine. Fda safety report id# (b)(4).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEDM LUMBAR CATHETER
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
MDR Report Key11677908
MDR Text Key246029653
Report NumberMW5100812
Device Sequence Number1
Product Code JXG
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 04/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number46420
Device Lot Number0220884648
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/14/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/15/2021 Patient Sequence Number: 1
-
-