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

Model Number UNKNOWN-S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Hemorrhage, Subdural (1894)

Event Type  Injury  

Manufacturer Narrative

Age or date of birth: 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.Sex: 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

Hideki kanemoto, hiroaki kazui, takashi suehiro, haruhiko kishima, yukiko suzuki, shunsuke sato, shingo azuma, takuya matsumoto, kenji yoshiyama, eku shimosegawa, toshihisa tanaka, manabu ikeda."apathy and right caudate perfusion in idiopathic normal pressure hydrocephalus: a case-control study." international journal of geriatric psychiatry 2018.Doi: 10.1002/gps.5038.Objectives: apathy is prevalent in patients with idiopathic normal pressure hydrocephalus (inph), a treatable disorder resulting from ventricular enlargement.We assessed the relationship between apathy and regional cerebral blood flow (rcbf) in patients with inph.Methods: before lumbo-peritoneal shunt surgery (lps), 56 inph patients were evaluated on apathy and dysphoria subscales of the neuropsychiatric inventory (npi), and were divided into two groups according to npi apathy score: 15 without apathy (inph-apa) and 41 with apathy (inph+apa).Among inph+apa, 29 patients were evaluated for apathy and dysphoria 3 months after lps, and were divided into two groups on the basis of the change in npi apathy score: 13 with improvement (inph+impapa) and 16 without improvement in apathy (inph-impapa).Nisopropyl- p-iodoamphetamine single photon emission computed tomography using the autoradiography method was performed before and after lps, and rcbf was calculated in 22 regions of interest in the frontal cortex, basal ganglia, and limbic system.Results: in inph+apa, rcbf in the right caudate nuclei before lps was significantly lower than that in inph-apa (p = 0.004; two-sample t test).Between inph-impapa and inph+impapa, a significant group-by-shunt interaction was observed for rcbf in only the right caudate nuclei (f1, 28 = 11.75, p = 0.002; two-way repeated-measures analysis of variance), with increased rcbf in inph+impapa but not in inph-impapa.The significant group-by-shunt interaction persisted if change in npi dysphoria scores was used as a covariate (f1, 27 = 8.33, p = 0.008).Conclusions: our findings suggest that right caudate dysfunction might cause apathy in inph patients.Reported events.1 patient experienced a subdural hematoma within 3 months following lps.

• Brand Name: UNKNOWN STRATA VALVE/SHUNT
• Type of Device: SHUNT, 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 Key: 8487324
• MDR Text Key: 141055895
• Report Number: 2021898-2019-00140
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-S
• Device Catalogue Number: UNKNOWN-S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR