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

Model Number	42355
Medical Device Problem Codes	Mechanics Altered (2984); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Vomiting (2144)
Date of Event	09/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported the patient exhibited vomiting, and the valve needed to be readjusted.The patient's status at the time of the report was alive-no injury.Additional information received reported the patient had a fall 3 days before the re-adjustment occurred from 1 meter height.It was stated the device was re-adjusted from 1.5 where it was found to the initial 2.0.The patient was doing great without any symptoms or any other signs of adjustment issues.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported the valve was explanted on (b)(6) 2018.
Additional Manufacturer Narrative
The returned valve was patent.It met the requirements for reflux, leak testing, and valve flux test, pressure-flow, and preimplantation.The pl settings on the valve were able to be adjusted without any interference by lab personnel.Therefore, the complaint could not be duplicated.There was proteinaceous debris noted within the interior of the valve.The instructions for use (ifu) that accompany the device cautions that ¿introduction of contaminant could result in improper performance of the shunt system.Particulate matter that enters the shunt system may result in shunt occlusion.¿ there was damage noted on the inlet connector.It is unknown how or when the damaged occurred.The ifu that accompanies the product cautions that, ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting or crushing of components¿.¿.All valves are 100% tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information confirmed that the valve was not de-regulated and then adjusted.The valve was on initial adjustment without any de-regulation.The surgeon decided to adjust the valve from the initial setting of 1.5 to 2.0 according to his therapy.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information received stated that the patient born was suffering from craniosynostosis.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information received clarified that the patient was admitted due to vomiting during the post-op period.The patient had a ct where the valve was indeed at 1.5, which matched the original adjustment of the valve.The surgeon resolved the symptoms by adjusting the valve to 2.0.On (b)(6), the patient was re-admitted urgently due to vomiting, and the valve was found de-regulated at 0.5 without exposure to mri.The valve was re-adjusted to 2.0, and the patient also had a ct.It was noted the patient had fallen 3 days before the "de-regulation" event from a height of 80-90cm.

• Brand Name: STRATA NSC VALVE, SMALL
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7938826
• Report Number: 2021898-2018-00486
• Device Sequence Number: 2052213
• Product Code: JXG
• UDI-Device Identifier: 00643169466920
• UDI-Public: 00643169466920
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K033850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 02/27/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 42355
• Device Catalogue Number: 42355
• Device Lot Number: E23053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 10/30/2018; 12/04/2018; 01/07/2019; 01/07/2019; 01/18/2019; 01/30/2019
• Initial Report FDA Received Date: 10/05/2018
• Supplement Report FDA Received Date: 11/14/2018; 12/06/2018; 01/07/2019; 01/07/2019; 01/23/2019; 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 8 MO