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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROSURGERY LUMBAR CATHETER KIT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 44405
Device Problem Complete Blockage (1094)
Patient Problem Insufficient Information (4580)
Event Date 12/28/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient was not draining according to regulation. The patient's status at the time of the report was alive-no injury. Additional information confirmed that the implant date of the device was (b)(6) 2020. As a result of the issue the device was replaced with that of a different model. Additional information received reported that the patient also had a ventricular shunt implanted. The ventricular shunt was performing accordingly, but the patient was not getting better. Several adjustments were attempted with both the ventricular and lumbar shunts, but the patient would only get better for 24-48 hours maximum. Troubleshooting was done with several maneuvers which were changing the settings of the valves to make sure that it was draining correctly, x-rayed the valve to confirm it's settings, and tried flushing the occluder; however, it was discovered that they did not anchor the shunt. All of these attempts were not satisfactory. During the revision, the doctor started by inspecting the shunt. Then, they disconnected the lumbar catheter and that was where it was discovered that the lumbar catheter was clogged. The doctor proceeded to change the lumbar catheter, which they visualized liquid being drained through the catheter. The doctor then decided to the change the valve as well as an extra safety measure. Since the revision, the patient has been much better and have not had to make adjustments to the shunts.
 
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Brand NameLUMBAR CATHETER KIT
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
5290 california ave
irvine CA 92617
Manufacturer (Section G)
MEDTRONIC NEUROSURGERY
5290 california ave
irvine CA 92617
Manufacturer Contact
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key11828780
MDR Text Key251181039
Report Number2021898-2021-00115
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K091312
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number44405
Device Catalogue Number44405
Device Lot NumberE71445
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/05/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured11/14/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/14/2021 Patient Sequence Number: 1
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