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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 Infarction, Cerebral (1771); Hematoma (1884); Hemorrhage, Subdural (1894); Complaint, Ill-Defined (2331); Meningitis (2389)
Event Date 04/23/2018
Event Type  Injury  
Manufacturer Narrative
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
Madoka nakajima, masakazu miyajima, chihiro akiba,md, ikuko ogino, kaito kawamura, hidenori sugano, takeshi hara, yuichi tange, keiko fusegi, kostadin karagiozov, hajime arai. "lumboperitoneal shunts for the treatment of idiopathic normal pressure hydrocephalus: a comparison of small-lumen abdominal catheters to gravitational add-on valves in a single center. " operative neurosurgery 15 (2018). Doi: 10. 1093/ons/opy044. Background: treating idiopathic normal pressure hydrocephalus (inph) with lumboperitoneal shunts (lpss) may cause cerebrospinal fluid (csf) overdrainage. Objective: to investigate whether lpss, including gravitational ¿add-on¿ and programmable pressure valves (ppvs/+gvs), reduce complications and improve outcomes. Methods: we compared ppvs/+small lumen abdominal catheters (sls) to ppvs/+gvs using different opening pressures for supine and standing positions. We analyzed 115 patients with inph in 2 consequent cohorts: 48 patients receiving lpss with ppvs/+sls and 67 patients receiving lpss with ppvs/+gvs. The modified rankin scale (mrs), japan inph grading scale, mini mental state examination, frontal assessment battery, and csf biomarkers were evaluated. Results: comparisons of postoperative clinical factors in 64 patients in the ppv/+sl and ppv/+gv groups using 1:1 propensity score matching revealed differences in the mean (±standard deviation) postoperative mrs (2. 65 ± 1. 07 vs 2. 16 ± 1. 02, p
=
. 049) and gait disturbance scores (1. 97 ± 1. 03 vs 1. 39 ± 0. 92, p
=
. 011). Thus, outcomes improved in the lps group with the gv. Serious and nonserious adverse event rates for the ppv/+sl and ppv/+gv groups were 22. 9% and 19. 4% (p
=
. 647) and 38% and 17. 9% (p
=
. 018), respectively, indicating higher rates of subdural collections for the ppv/+sl group. Conclusion: this is the first study to examine lps treatment for inph using a gv in tandem with a ppv. Our results suggest that the csf shunt flow volume is restricted in the standing position and maintained in the supine position, thus improving inph symptoms. This may reduce intracranial csf hypotension-related complications. Reported events: the rates of asymptomatic subdural effusions and subdural hematomas (conservatively treated) were 8. 3% (n
=
4/48) and 3% (n
=
2/67) in the ppv/+sl and ppv/+gv groups, respectively (p
=
. 203). The rates of chronic subdural hematomas requiring surgery were 3. 9% (n
=
2/48) and 0% in the ppv/+sl and ppv/+gv groups, respectively (p
=
. 092). The rates of meningitis in the ppv/+sl and ppv/+gv groups were 2. 1% (n
=
1/48) and 1. 5% (n
=
1/67), respectively (p
=
. 811). The rates of cerebral infarction in the ppv/+sl and ppv/+gv groups were 4. 1% (n
=
2/48) and 1. 5% (n
=
1/67), respectively (p
=
. 375).
 
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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
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key8189840
MDR Text Key131168367
Report Number2021898-2018-00584
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 12/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/21/2018
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 Received12/04/2018
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: 12/21/2018 Patient Sequence Number: 1
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