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

Model Number	96665
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/02/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was that during the procedure, fluid such as cerebrospinal fluid (csf) did not drain smoothly when pumping was performed using csf and saline.Therefore, the use of the devices were discontinued.Per the physician, the flow back from the reservoir was slow and discharge of the csf could not be observed.As further difficulties were expected in checking the device operation once they were placed subcutaneously, the use of the devices were discontinued.After implanting a part of the lumbar catheter in the patient, a backup lumbar peritioneal (lp) shunt was unpacked and connected with the lumbar catheter and lp valve, and further connected with the lp shunt.It was noted that the proximal edge of the lumbar catheter had remained inside the patient's body.The distal edge was explanted.
Additional Manufacturer Narrative
The returned valve was patent and met the requirements for reflux, pressure-flow, pre-implantation and leak testing.No anomalies were observed.All valves are 100% tested at the time of manufacture.Approximately 91 cm of the catheter was returned.The returned catheter was patent and met the requirements for leak testing.All catheters are 100% inspected at the time of manufacture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STRATA NSC SHUNT ASSEMBLY, WITH BIOGLIDE
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7068834
• Report Number: 2021898-2017-00612
• Device Sequence Number: 118058
• Product Code: JXG
• UDI-Device Identifier: 00643169472938
• UDI-Public: 00643169472938
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K033850
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2018

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: 08/31/2020
• Device Model Number: 96665
• Device Catalogue Number: 96665
• Device Lot Number: E05521
• 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: 11/02/2017
• Supplement Date Received by Manufacturer: 12/21/2017
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 01/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1