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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA® SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC NEUROSURGERY STRATA® SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 42856
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/14/2022
Event Type  Injury  
Event Description
Medtronic received information regarding a valve. The patient symptoms were consist with the past shunt malfunctions. No runoff through valve were seen when tested intraoperatively. The ventricular catheter was also occluded, both are going to be replaced with different products. Additional information was received. It was reported that the patient's symptoms were unknown. It was also unknown if any environmental/external/patient factors may have led or contributed to the issue. It was confirmed that the catheter was occluded.
 
Manufacturer Narrative
No products have been returned to medtronic for analysis. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSTRATA®
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
glen belmer
9775 toledo way
irvine, CA 92618
6122713209
MDR Report Key13978565
MDR Text Key289498807
Report Number2021898-2022-00085
Device Sequence Number1
Product Code JXG
UDI-Device Identifier00613994804631
UDI-Public00613994804631
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042465
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2015
Device Model Number42856
Device Catalogue Number42856
Device Lot NumberD34067
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/20/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/01/2022 Patient Sequence Number: 1
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