MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA 2 VALVE, REGULAR; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number 42866

Device Problems Inaccurate Flow Rate (1249); Occlusion Within Device (1423); Mechanics Altered (2984); Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Headache (1880); Pain (1994); Visual Disturbances (2140); Twitching (2172); Discomfort (2330); Complaint, Ill-Defined (2331); Cognitive Changes (2551); Insufficient Information (4580)

Event Type  malfunction  

Manufacturer Narrative

The product was unavailable for return as it remains implanted.Therefore an evaluation of device performance was not possible.A review of the manufacturing records showed no anomalies.The strata valve was implanted prior to the shelf life expiration date.All valves are 100% tested at the time of manufacture.(b)(4).

Event Description

It was reported to medtronic neurosurgery that an implanted strata valve is past its expiration date and has become deformed inside the patient, causing harm.The report stated the alleged strata valve expiration date was (b)(6) 2012.Update 1/27/2016: upon further follow up, it was reported that a strata valve and competitor catheters were implanted on (b)(6) 2007.The report stated that the expiration date for the competitor catheters, per the patient card, was (b)(6) 2007 and the concern was that the catheters had been implanted in the same month as the catheters expiration date.According to the report the patient had chiari malformation and has had three brain surgeries.Reportedly, the patient is experiencing swelling along the shunt, pain and deterioration in hearing.

Manufacturer Narrative

The product was unavailable for return as it remains implanted.Therefore, an evaluation of device performance was not possible.A review of the manufacturing records showed no anomalies.The strata valve was implanted prior to the shelf life expiration date.All valves are 100% tested at the time of manufacture.Additional patient/device information: it was reported to medtronic neurosurgery that the device was clogging and not draining properly.It was also reported that shunt setting was not checked before or after the patient had an mri.The report stated that the mri caused the shunt to become warped to a pointed shape.Reportedly, the shunt is causing neck jerking in the patient.It was also reported that there is a bump on the patient's head where the shunt lies and that over time the bump has gotten more pronounced.The report also stated that the patient has surgical instability, an atypical seizure pattern, a tethered cord in the thoracic area and a slit ventricle on the right side.The patient's weight was reported as (b)(6).Additionally, it was reported that the patient had last visited their doctor's office in (b)(6) 2013 due to headaches and discomfort.According to the report, shunt evaluation at the time revealed that the shunt and ventricular system was stable.(b)(4).

Manufacturer Narrative

Additional information received reported the device was blocked.According to the report, it was also stated the device was overdraining at all settings since implant.Reportedly, the device had been at the 2.0 setting since (b)(6) 2016 and a ct scan showed it was overdraining.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.

Manufacturer Narrative

Correction: malfunction was inadvertently selected in the previously submitted supplemental regulatory report.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.

Manufacturer Narrative

Information received reported the patient had adult encephalomalacia, ¿rare, progressive.¿ according to the report, it started in the frontal lobe and moved to the hind brain.It was stated the patient experienced ¿ear symptoms, eye symptoms, mentation changes, pain, and photophobia.It was noted that sound caused pain and the patient was ¿very ill.¿ manufacturer contact information updated.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.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information received reported the shunt ¿vibrated¿ and ¿changed by itself.¿ the valve was initially implanted at a setting of 1.5.It in addition to the previously reported chiari malformation, the patient also had a small posterior fossa, had undergone posterior decompression ¿multiple times,¿ and had a dural patch.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information received reported the patient was in 24-hour home care.It was stated the patient was developmentally disabled.

Event Description

Medtronic received information regarding a strata valve.It was reported that the patient was experiencing health problems.The patients mother reported that the patient had "over 110 high-dose ct scans" of her brain.The patient's mother also stated that an expired device was implanted in the patient.The device was positioned incorrectly with the catheter, and that the shunts was not draining correctly as well as it was blocked with the shunt.The patient suffered from brain damage including encephalomalacia.The patient has suffered seizures and head pain and even respiratory failure in 2022.The patient's mother goes on to say that they have concerns that "they have never run a shuntogram".They also stated that they device vibrates and causes the patient pain.

Manufacturer Narrative

H2) additional information was added to b5.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.

• Brand Name: STRATA 2 VALVE, REGULAR
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 5434160
• MDR Text Key: 38135781
• Report Number: 2021898-2016-00061
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/30/2010
• Device Catalogue Number: 42866
• Device Lot Number: A99606
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/22/2007
• 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; Disability; Required Intervention
• Patient Sex: Female
• Patient Weight: 170 KG