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

Model Number	44421
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/06/2017
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 an attempt was made to change preset pressure but failed.A back-up lumbar peritoneal valve was used to set up pressure.The procedure was completed without further issue.Additional information received reported that when the manufacturer's representative (rep) received the product and attempted to adjust the setting, and they could adjust it.The setting was at performance level 2.5.The rep thought personally that the doctor tried to adjust by rotating clockwise, and the setting was coming and going between performance level 2.0 and 2.5 so then the doctor might have thought that the setting was unavailable to be changed because the initial setting was usually performance level 0.5.The doctor reported that the setting pressure was unavailable to be adjusted at first, however, the rep confirmed the details.They heard that the setting would be set between performance level 2.0 and 2.5, and the doctor understood the setting.It was noted that the performance level was able to be set within the blue range except 2.0.Only 2.0 was not able to be set within the blue range, but 2.0 was able to be set within the white range.
Additional Manufacturer Narrative
The returned valve was received within the product tray.All performance levels could be set with a single attempt, and the valve did not spontaneously change levels during the course of analysis.Therefore the conditions of this complaint could not be verified by laboratory personnel.All valves are 100% tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRATA NSC LUMBOPERITONEAL SHUNT KIT
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7000811
• Report Number: 2021898-2017-00559
• Device Sequence Number: 11085778
• Product Code: JXG
• UDI-Device Identifier: 00643169010789
• UDI-Public: 00643169010789
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2017

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: 01/31/2022
• Device Model Number: 44421
• Device Catalogue Number: 44421
• Device Lot Number: E27073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2017
• Supplement Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 11/03/2017
• Supplement Report FDA Received Date: 12/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1