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

Model Number 96665

Device Problem Inaccurate Flow Rate (1249)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/02/2017

Event Type  malfunction  

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 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.

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
• 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: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 7068834
• MDR Text Key: 93501257
• Report Number: 2021898-2017-00612
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00643169472938
• UDI-Public: 00643169472938
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K033850
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2016
• 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