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

Model Number UNKNOWN-A

Device Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Headache (1880); Vomiting (2144)

Event Date 07/17/2020

Event Type  Injury  

Manufacturer Narrative

Patient age is the mean value of patients in the study.Patient gender is the majority value of patient in the study.Patient weight not available from the site.Event date is the online publishing date of the literature article.Device lot number, or serial number, unavailable.510(k) is dependent upon the device model number and therefore, unavailable.No parts have been received by the manufacturer for evaluation.Device manufacturing date is dependent on lot number/serial number, therefore, unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Quezada, j.J., mccomb, j.G.Reliability of the radiopharmaceutical shunt flow study for the detection of a csf shunt malfunction in the presence of stable ventricular size.J neurosurg pediatr.2020 (26) 364¿370.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 (b)(6) 2014, and (b)(6) 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 events: the valve was changed in order to lower the drainage pressure, patient symptoms consisting of lethargy and emesis.Nine of these 112 shunt flow examinations (8%) were determined to be false-negative after surgical intervention confirmed a malfunctioning shunt all 9 of the patients in these cases underwent surgical shunt exploration because of persistent headache and emesis see attached literature article.

• Brand Name: DELTA®
• 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: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 14213357
• MDR Text Key: 290115514
• Report Number: 2021898-2022-00107
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K902783
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: UNKNOWN-A
• Device Catalogue Number: UNKNOWN-A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: No
• 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: 13 YR
• Patient Sex: Female