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

Model Number UNKNOWN-S

Device Problem Infusion or Flow Problem (2964)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Meningitis (2389)

Event Date 11/02/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Matheus fernandes de oliveira, a.A.Boa sorte jr, d.L.Emerenciano, j.M.Rotta, g.A.S.Mendes, f.C.G.Pinto.Long term follow-up of shunted idiopathic normal pressure hydrocephalus patients: a single center experience.Acta neurologica belgica (2020).Doi: 10.1007/s13760-020-01538-5 abstract idiopathic normal pressure hydrocephalus (inph) is a condition characterized by gait disturbance, dementia and/or urinary incontinence and enlarged ventricular system due to disturbance of cerebrospinal fluid (csf).This study aims to describe the long-term experience with patients with inph submitted to ventriculoperitoneal shunt (vps) with the programmable valve strata® (medtronic).We prospectively selected a cohort of patients with a diagnosis of inph from january 2010 to april 2013 in a brazilian tertiary hospital.All patients underwent clinical evaluation, which consists of the mini-mental state examination and time up and go tests and the application of japanese scale for idiopathic normal pressure hydrocephalus in three stages: prior to the tt, 3 h after the tt and 72 h after the tt.Fifty patients were submitted to vps and followed.There were 32 men and 18 women.Mean age was 77.1 with standard deviation of 10.9.Follow-up time ranged from 96 to 120 months, with mean of 106 months.After 1 year of follow-up, 42 (83%) patients presented with clinical improvement, decreasing to 62% of patients at mid-term follow-up and 38% of patients at late follow-up.Complications occurred in 18% of subjects, needing reoperation in 16%.Our results show relevant clinical impact of shunting in inph patients, decreasing over time.Complications should not be underestimated, reaching up to 18% and demanding reoperation in 16% of cases.Thus, although much has been improved with current shunt technology, it is still important to consider the drawbacks of treatment.Reported events.- subdural collections occurred in two patients.All were managed with surgical treatment.- malfunctioning of the valve forced the valve revision in two patients.- one patient presented with wound dehiscence and valve exposure after 6 months of the surgery, and it was necessary to remove the valve.- we had also two cases of shunt infection and meningitis which needed reoperation and antibiotics - there was a retroauricular wound dehiscence and shunt exposure which needed reoperation and valve change.

• Brand Name: UNKNOWN STRATA VALVE/SHUNT
• Type of Device: SHUNT, 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: tricha miles ; 9775 toledo way; irvine, CA 92618 ; 7635140379
• MDR Report Key: 11233215
• MDR Text Key: 229118032
• Report Number: 2021898-2021-00028
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• 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: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 01/04/2021
• 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): Hospitalization; Required Intervention