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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CSF-FLOW CONTROL SHUNT KIT BURR HOLE, 16 MM, LOW PRESSURE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
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MEDTRONIC NEUROSURGERY CSF-FLOW CONTROL SHUNT KIT BURR HOLE, 16 MM, LOW PRESSURE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 9040 D
Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/18/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported the chamber on the shunt did not function normally intra-operatively.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received reported that the valve malfunctioned before the doctor used it on the patient.It was stated the fluid could not flow.
 
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Brand Name
CSF-FLOW CONTROL SHUNT KIT BURR HOLE, 16 MM, LOW PRESSURE
Type of Device
SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
125 cremona drive
goleta CA 93117
MDR Report Key9226437
MDR Text Key167842071
Report Number2021898-2019-00372
Device Sequence Number1
Product Code JXG
UDI-Device Identifier00643169472730
UDI-Public00643169472730
Combination Product (y/n)N
PMA/PMN Number
K831678
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 11/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/31/2023
Device Model Number9040 D
Device Catalogue Number9040 D
Device Lot NumberE54030
Was Device Available for Evaluation? No
Date Manufacturer Received11/09/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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