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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY UNKNOWN STRATA VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

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MEDTRONIC NEUROSURGERY UNKNOWN STRATA VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number UNKNOWN-S
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Meningitis (2389); Bowel Perforation (2668)
Event Date 10/31/2020
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Nadia mansoor & ole solheim & oddrun a. Fredriksli & sasha gulati. Revision and complication rates in adult shunt surgery: a single-institution study. Acta neurochirurgica 163 (2021). Doi: 10. 1007/s00701-020-04526-z. Abstract background csf diversion with shunt placement is frequently associated with need for later revisions as well as surgical complications. We sought to review revision and complication rates following ventriculoperitoneal, ventriculoatrial and cystoperitoneal shunt placement in adult patients, and to identify potential risk factors for revision surgery and postoperative complications. Method included patients were adults (
=
(b)(6) years) who underwent primary shunt insertion at st. Olavs hospital in trondheim, norway, from 2008 through 2017. The electronic medical records and diagnostic imaging from all hospitals in our catchment area were retrospectively reviewed. Follow-up ranged from 1 to 11 years. Complications were graded according to the landriel ibañez classification system. Results of the 227 patients included, 47 patients (20. 7%) required revision surgery during the follow-up. In total, 90 revision surgeries were performed during follow-up. The most common cause for the first revision was infection (5. 7%) and for all revisions proximal occlusion (30. 0%). A total of 103 patients (45. 4%) experienced
=
1 complication(s). Mild to moderate complications (grade i and ii) were detected in 35. 0% of all procedures. Severe or fatal complications (grade iii and iv) were observed in 8. 2% of all procedures. Urinary tract infections and pneumonia were common postoperatively (13. 9% and 7. 3%, respectively), and the most common iib complication was shunt misplacement (proximally or distally). Two out of fourteen deaths within 30 days were directly associated with surgery. We did not find that aetiology/indication, age or gender influenced the occurrence of revision surgery or a grade iii or iv complication. Conclusions shunt surgery continues to be a challenge both in terms of revision rates and procedure-related complications. However, the prediction of patients at risk remains difficult. A multidimensional focus is probably needed to reduce risks. Reported events. - grade iv complications were classified as death occurring within 30 days of surgery regardless of cause. This was the case for fourteen patients; two patients died as a direct result of surgery/complication to surgery, and both died within a week of surgery (one instance of bowel perforation and one instance of acute aggressive meningitis). The remaining twelve patients died due to their underlying primary illness (acute subarachnoid haemorrhage, traumatic brain injury and primary extracranial malignancy) and one patient died of acquired illness/injury postoperatively. This latter case was a patient who received a shunt for nph. The patient suffered a severe head trauma shortly after discharge, resulting in anacute subdural haematoma; due to severe clinical presentation, the patient was deemed not fit for surgical intervention and subsequently died within 30 days of shunt implantation.
 
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Brand NameUNKNOWN STRATA VALVE/SHUNT
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 Key11806940
MDR Text Key250006414
Report Number2021898-2021-00109
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeNO
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN-S
Device Catalogue NumberUNKNOWN-S
Device Lot NumberUNKNOWN
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 Received04/28/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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: 05/11/2021 Patient Sequence Number: 1
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