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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 Problems Fluid Leak (1250); Appropriate Term/Code Not Available (3191)
Patient Problems Headache (1880); Hematoma (1884); Hemorrhage, Subdural (1894); Unspecified Infection (1930); Seroma (2069); Therapeutic Effects, Unexpected (2099)
Event Type  Injury  
Manufacturer Narrative
Other applicable components are: product id: unknown-a, serial/lot #: unknown. Please note that this age is the average age of the patients reported in the article, as the actual age of patients involved was not provided. Please note that this is the gender of the majority of patients reported in the article as the actual genders of patients involved was not provided. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Eduardo orrego-gonzález, alejandro enriquez-marulanda, luis c. Ascanio, noah jordan, khalid a. Hanafy, justin m. Moore, christopher s. Ogilvy, ajith j. Thomas. A cohort comparison analysis of fixed pressure ventriculoperitoneal shunt valves with programmable valves for hydrocephalus following nontraumatic subarachnoid hemorrhage. Operative neurosurgery 0 (2019). Doi: 10. 1093/ons/opz195. Background: hydrocephalus after nontraumatic subarachnoid hemorrhage (sah) is a common sequela that may require the placement of ventriculoperitoneal shunts (vps). Adjustable-pressure valves (apvs) are being widely used in this situation though more expensive than differential-pressure valves (dpvs). Objective: to compare outcomes between apv and dpv in sah-induced hydrocephalus. Methods: we performed a retrospective chart review of patients with nontraumatic sah who underwent vps placement for the treatment of hydrocephalus after sah, between july 2007 and december 2016. Patients were classified according to the type of valve (apv vs dpv). We evaluated factors that could predict the type of valve used, outcomes in vps revision/replacement rate, and complications. Results: a total of 66 patients underwent vps placement who were equally distributed into the 2 groups of valves. Vps failure with the need for revision/replacement occurred in 13 (19. 7%) cases. Ten (30. 3%) patients with dpv had a vps failure, while 3 (9. 1%) patients with an apv had a similar failure with the need for revision/replacement (p
=
. 03). Vps placement before discharge during the initial hospitalization(p
=
. 02) was statistically significant associated with the use of a dpv, while the reason of external ventricular drain (evd) failure (p
=
. 03) was associated with the use of an apv. Conclusion: apvs had a lower rate of surgical revisions compared to dpvs. Early placement of vps was associated with the use of a dpv. The need for evd replacement due to evd infection or malfunction was associated with higher rates of apv use. Reported events. - most patients (69. 7%) had a good functional outcome at last clinical follow-up. Thirteen (19. 7%) patients required a vps revision with subsequent replacement of 1 or more of the components of the vps system. Proximal catheter replacement was recorded in 5 (7. 6%) cases, distal catheter in 7 (10. 6%) cases, and valve replacement in 12 (18. 2%) cases. The reasons for replacement of 1 or more of the vps system components was due to infection (n
=
4; 30. 8%), obstruction (n
=
4; 30. 8%), overdrainage (n
=
2; 15. 3%), underdrainage (n
=
1; 7. 7%), shunt hardware exposure (n
=
1; 7. 7%), and shunt malposition(n
=
1; 7. 7%). The reasons for valve replacement recorded in the dpv group (n
=
10) were obstruction in 2 cases, infection in 4 cases, overdrainage in 2 cases, underdrainage and enlarged ventricles in 1 case (underwent surgical revision and replacement with an apv), and shunt exposure in 1 case. With the 2 overdrainage cases, 1 patient experienced a hygroma and the other case complained of headaches refractory to medical therapy. Both cases were revised and replaced with an apv. For the apv group, there were only 2 cases with a valve replacement performed and the reason in 1 case was obstruction, and in the other one was misplacement. 1 patient in the apv group experienced a subdural hematoma (sdh) due to overdrainage. The patient was treated with a pressure level adjustment in which it was changed from 0. 5 to 2. 5.
 
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Brand NameUNKNOWN STRATA VALVE/SHUNT
Type of DeviceSHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
125 cremona drive
goleta CA 93117
Manufacturer (Section G)
MEDTRONIC NEUROSURGERY
125 cremona drive
goleta CA 93117
Manufacturer Contact
katcha taylor
9775 toledo way
irvine, CA 92618
7635263305
MDR Report Key9246276
MDR Text Key178762694
Report Number2021898-2019-00382
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 10/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
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 Received10/11/2019
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: 10/28/2019 Patient Sequence Number: 1
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