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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROSURGERY UNKNOWN VALVE/SHUNT SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number UNKNOWN-V
Device Problems Complete Blockage (1094); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Wound Dehiscence (1154); Cerebrospinal Fluid Leakage (1772); Hematoma (1884); Intracranial Hemorrhage (1891); Unspecified Infection (1930); Paresis (1998); Pneumonia (2011); Urinary Tract Infection (2120); Meningitis (2389); Post Operative Wound Infection (2446); Respiratory Failure (2484); Convulsion/Seizure (4406)
Event Date 09/27/2021
Event Type  Injury  
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. Shunt complications and revisions in children: a retrospective single institution study. Brain behavior 11 (2021). Doi: 10. 1002/brb3. 2390 abstract introduction: shunt surgery in children is associated with high revision and complication rates. We investigated revision rates and postoperative complications to specify current challenges associated with pediatric shunt surgery. Methods: all patients aged <(><<)> 18 years admitted to st. Olavs university hospital, norway, from january 2008 through december 2017, who underwent primary shunt insertions, were reviewed. Follow-up ranged from 1 to 10 years. Ventriculoperitoneal, cystoperitoneal, and ventriculoatrial shunts were included. All subsequent shunt revisions and 30-day postoperative complication rates were registered. Results: 81 patients underwent 206 surgeries in the study period. 47 patients (58%) required minimum one revision during follow-up. In 14 (29. 8%), the first revision was due to the misplacement of hardware. Proximal occlusion was the most common cause of revision (30. 4%), followed by misplacement (18. 5%) and infection (9. 6%). Young age and mmc were associated with revision surgery in a univariable analysis, but were not significant in multivariable analyses. Congenital hydrocephalus was associated with infection (p
=
. 028). In approximately 30% of procedures, complications occurred within 30 days postoperatively, the most common being revision surgery. In approximately 5% of the procedures,medical complications occurred. Conclusion: children are prone to high revision and complication rates, and in this study,misplacement of hardware and proximal occlusion were the most common. Complication rates should not be limited to revision rates only, as 30-day complication rates indicate a significant rate of other complications as well. Multi-targeted approaches, perhaps focusing on measures to reduce misplacement, may be key to reducing revision rates. Reported events. - a total of 125 revision surgeries were performed during the follow up period. 47 out of 81 (58. 0%) patients underwent revision surgery at some point during follow-up. The following are the causes of the revisions: 23 misplacements, 38 proximal occlusions, 9 elective valve changes, 12 infections, 6 valve dysfunctions, 2 lengths, 7 explorations,5 csf leaks, 3 shunt removals, 11 distals, 2 shunt conversions, 2 skin perforations, and 5 new shunt/valve. - a total of 30. 6% of all procedures were followed by complications within 30 days. Descriptions of the complications are as followed: 1 epileptic seizure, not requiring aed; 1 track hematoma, not requiring surgery; 3 pneumonias, treated with antibiotics; 2 utis, treated with antibiotics; 2 infections, unknown source, treated with antibiotics; 1 local wound infection, treated with antibiotics; 2 epileptic seizures, requiring aed; 1 dehiscent wound requiring closure; 35 shunt revision, any kind; 1 chronic subdural hematoma, requiring surgery twice; 1 csf leakage, requiring duraplasty; 1 respiratory failure requiring reintubation; 7 meningitis/csf infection (also leading to shunt removal/externalization); 1 n. Recurrent paresis after traumatic intubation and was reintubated. It was indicated that the 29 medtronic strata ii and 13 medtronic ultra small were revised as well as other manufacturers.
 
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Brand NameUNKNOWN 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
glen belmer
9775 toledo way
irvine, CA 92618
6122713209
MDR Report Key13019207
MDR Text Key284115196
Report Number2021898-2021-00220
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,Literature,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN-V
Device Catalogue NumberUNKNOWN-V
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/03/2021
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: 12/16/2021 Patient Sequence Number: 1
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