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

Model Number UNKNOWN-A

Device Problems Complete Blockage (1094); Infusion or Flow Problem (2964)

Patient Problems Headache (1880); Blurred Vision (2137); Swelling/ Edema (4577)

Event Date 12/27/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Jordan xu, cassie poole, ronald sahyouni, jefferson chen.Noninvasive thermal evaluation for shunt failure in the emergency room.Surgical neurology international 10 (2019).Doi: 10.25259/sni_324_2019.Abstract background: ventriculoperitoneal shunts (vpss) have been the mainstay of treating hydrocephalus since the 1950's.However, shunts have a reported complication rate reaching nearly 50%.Devices have been developed that utilize noninvasive thermal transcutaneous diffusion technology.These shunt evaluation devices measure temperature gradients to detect shunt cerebrospinal fluid flow.We assessed the utility using a thermal diffusion technique to work up shunt failure in the emergency room (er).Methods: this was a retrospective case series at a single medical center er.We included consecutive patients with possible vps malfunction who were evaluated with a thermal sensor.The time period of data collection included september 2015¿april 2018.Results: eight patients were reviewed, including four males and four females.The average age of reviewed patients was 35.1 (+/- ; 16.5).In our case series, three patients had adequate shunt flow as assessed by the shunt evaluation device, and the decision was made to discharge the patient and follow-up in clinic.In two patients, the flow was diminished, but due to other reassuring signs, the patients were still discharged with follow-up.Two patients were noted to have poor flow and were admitted for shunt revision.Conclusion: it is important to determine whether a malfunction is present and whether an intervention is necessary for patients who present to the emergency department with possible symptoms of shunt failure.A thermal sensor is a fast and noninvasive tool in the evaluation of shunt flow and helps determine whether it is safe to send a patient home or intervene appropriately.Reported events: - patient 3: a (b)(6)-year-old female with a history of idiopathic intracranial hypertension and vps (medtronic delta) presented with headaches and blurry vision.Her shunt was placed 1 month before presentation at an outside hospital.Ct head imaging revealed slit ventricles.Lp revealed an opening pressure of 33 cm h2o.Ophthalmologic examination showed evidence of bilateral papilledema.Thermal sensor at 90° showed slow flow (nfa: 0.17).Given high suspicion of shunt failure, the patient was admitted for shunt revision.At the time of surgery, the proximal catheter was noted to have obstruction of flow and appeared adherent to the choroid.The proximal catheter was replaced along with a new medtronic strata valve.Follow-up appointment revealed the resolution of papilledema although headache persisted.

• 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: 12921336
• MDR Text Key: 286938740
• Report Number: 2021898-2021-00205
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/02/2021
• 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): Required Intervention; Hospitalization