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

Model Number UNKNOWN-V

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Bacterial Infection (1735); Intracranial Hemorrhage (1891); Fungal Infection (2419)

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

Ramin a.Morshed, anthony t.Lee, andrew egladyous, lauro n.Avalos, manish k.Aghi, philip v.Theodosopoulos, michael w.Mcdermott, shawn l.Hervey-jumper.Shunt treatment for coccidioidomycosis-related hydrocephalus: a single-center series.World neurosurgery (2020).Doi: 10.1016/j.Wneu.2020.03.135 objective: coccidioidomycosis is a fungal infection endemic to the southwestern united states.Hydrocephalus can develop after intracranial dissemination, and management of this disease entity is difficult.We present our institutional experience with shunting cocc idioidomycosisrelated hydrocephalus.Methods: a cohort of patients with coccidioidomycosisrelated hydrocephalus undergoing an intracranial shunt placement were retrospectively identified over a 24-year period.Demographics and treatment characteristics were obtained from the electronic medical record.Results: thirty patients undergoing 83 procedures were identified, with a median follow-up of 19.4 months.The average age of the cohort was 43 years at the time of initial shunt placement.Most patients (66.7%) had ¿1 shunt failure, and the average number of revisions required was 2.6 for patients who had shunt failure.The average shunt valve pressure threshold required was 5.5 cm h2o, and patients who harbored the disease for a longer period (>7 months) had a lower pressure setting for initial shunt valves.Shunts without an antisiphon component were more likely to be failure free on multivariate analysis (odds ratio, 9.2; 95% confidence interval, 2.4e35.7).Death was associated with a longer diagnosisto- shunt time interval, and patients having been diagnosed with intracranial disease for more than 10 months before shunt placement had significantly higher rates of death on follow-up.Conclusions: patients with coccidioidomycosisrelated hydrocephalus typically have normal to low pressure setting r equirements, high shunt failure rates, prolonged hospitalizations, and mortality.In this disease context, shunt valves without an antisiphon component are associated with lower shunt failure rates.Reported events.- 13 shunt infections were observed.There were 11 cases of bacterial infection and 2 cases of refractory fungal infection requiring shunt removal and further antimicrobial therapy.- 4 intracranial pressures below the shunt setting were observed.In 3 of these cases, a programmable shunt without an antisiphon component was placed with improvement in previous ventriculomegaly.- 1 intraparenchymal hemorrhage was observed.

• Brand Name: UNKNOWN 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: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 10089254
• MDR Text Key: 198690002
• Report Number: 2021898-2020-00150
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-V
• Device Catalogue Number: UNKNOWN-V
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2020
• 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
• Patient Age: 43 YR