MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA II SHUNT ASSEMBLY, REGULAR, WITH BIOGLIDE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	27819
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the device was prepared to be sent to the clinic for use during the operation, however, before the operation, the pressure needed to be adjusted to the level of 1.5 according to the doctor's request, and the pressure was measured to the level of 0.5.It was stated that the manual pressure regulator and the electric pressure regulator were used by multiple people with many attempts, but they failed to adjust the pressure value.It was noted that human factors and pressure regulator factors had been eliminated.It was considered that the valve had failed, and a new set had been requested.
Additional Manufacturer Narrative
The returned valve was patent.The valve met the requirements for valve flux testing, siphon control, reflux, leakage testing, pressure/flow and pre-implantation testing.No signs of damage were observed on the valve.The valve was able to get adjusted between different pl settings for the pressure flo w/preimplantation pressure testing.The laboratory personnel could not replicate the failure observed in the field.The ifu cautions, ¿the adjustment tool contains strong magnets.Care should be taken when using the tool near magnetically sensitive medical implants (e.G.Pacemakers and vagal nerve stimulators), electronic equipment, data storage devices such as computer diskettes or credit cards.¿ review of dhr for lot # e47749 did not indicate any defects related to the failure observed on the field.All valves are 100% tested at the time of manufacture.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 II SHUNT ASSEMBLY, REGULAR, WITH BIOGLIDE
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• MDR Report Key: 11046025
• Report Number: 2021898-2020-00371
• Device Sequence Number: 16470703
• Product Code: JXG
• UDI-Device Identifier: 00643169975637
• UDI-Public: 00643169975637
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 27819
• Device Catalogue Number: 27819
• Device Lot Number: E47749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 03/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1