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

Model Number UNKNOWN-A

Device Problem Insufficient Information (3190)

Patient Problems Vomiting (2144); Lethargy (2560)

Event Date 07/17/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Jeffrey j.Quezada and j.Gordon mccomb.Reliability of the radiopharmaceutical shunt flow study for the detection of a csf shunt malfunction in the presence of stable ventricular size.Journal of neurosurgery pediatrics 26 (2020).Doi: 10.3171/2020.4.Peds2020.Objective the authors sought to determine the reliability of a radiopharmaceutical (rp) shunt flow study for the detection of a csf- diverting shunt malfunction in the presence of stable ventricular size.Methods after the authors obtained irb approval, all csf rp shunt flow studies done between january 1, 2014, and january 1, 2019, in pediatric patients at children¿s hospital los angeles were identified.Included in the study were only those patients in whom an mri or ct scan was done during the hospital admission for shunt malfunction and showed no increase in ventricular size compared with the most recent prior mri or ct scan when the patient was asymptomatic.Data recorded for analysis were patient age and sex, etiology of the hydrocephalus, shunt distal site, nonprogrammable versus programmable valve, operative findings if the shunt was revised, and follow-up findings for a minimum of 90 days after admission.The rp shunt flow study consisted of tapping the reservoir and injecting technetium-99m dtpa according to a set protocol.Results the authors identified 146 rp flow studies performed in 119 patients meeting the above criteria.Four of the 146 rp studies (3%) were nondiagnostic secondary to technical failure and were excluded from statistical analysis.Of the 112 normal flow studies, operative intervention was not undertaken in 102 (91%).The 10 (9%) remaining normal studies were performed in patients who underwent operative intervention, in which 8 patients had a proximal obstruction, 1 had a distal obstruction, and 1 patient had no obstruction.Of the 30 patients with abnormal flow studies, symptoms of shunt malfunction subsided in 9 (30%) patients and these patients did not undergo operative intervention.Of the 21 (70%) operated patients, obstruction was proximal in 9 patients and distal in 5, and for 7 patients the shunt tubing was either fractured or disconnected.Regression analysis indicated a significant association between the flow study interpretation and the odds for shunt revision (or 27, 95% ci 10¿75, p <(><<)> 0.0001).No other clinical variables were significant.The sensitivity of a shunt flow study alone for detection of shunt malfunction in cases with stable ventricular size was the same as a shunt flow study plus an mri or ct (70% vs 70%), but performing a shunt flow in addition to mri or ct did increase the specificity from 92% to 100% and the accuracy from 87% to 94%.Conclusions rp shunt flow studies were of definite value in deciding whether to operatively intervene in patients with symptoms of shunt malfunction in whom no change in ventricular size was detected on current mri or ct scans compared to scans obtained when the patients were asymptomatic.Reported event.- in 1 case for which the patient had a normal flow study, shunt patency was confirmed intraoperatively, but the valve was changed in order to lower the drainage pressure because of the patient¿s persistent symptomatology consisting of lethargy and emesis.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received reported that per the author, there were no adverse events.There were 4 technical failures secondary to injection technique that had no relation to the manufacturer's valves.

• Brand Name: UNKNOWN DELTA VALVE/SHUNT
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• MDR Report Key: 10840732
• MDR Text Key: 217970019
• Report Number: 2021898-2020-00336
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-A
• Device Catalogue Number: UNKNOWN-A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention