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

Model Number UNKNOWN-V

Device Problems Complete Blockage (1094); Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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 coccidioidomycosis related hydrocephalus.Methods: a cohort of patients with coccidioidomycosis related 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, (b)(4) confidence interval, 2.4e35.7).Death was associated with a longer diagnosis to- 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 coccidioidomycosis related hydrocephalus typically have normal to low pressure setting requirements, 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.- 24 catheter/valve obstructions were observed.Shunt obstruction was often caused by thick fungal film that obstructed the catheter or valve itself.- 1 inability to change the programmable shunt setting 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: 10089207
• MDR Text Key: 195971194
• Report Number: 2021898-2020-00149
• 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?: No
• Is this a Product Problem 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 Age: 43 YR