MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CSF-FLOW CONTROL SHUNT KIT BURR HOLE, 16 MM, MEDIUM PRESSURE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	9040 E
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/03/2019
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 catheter had loose elasticity.The surgeon used another manufacturer's product to complete the surgery.The patient's status at the time of the report was alive-no injury.
Additional Manufacturer Narrative
The returned device included a burr hole valve, cardiac/peritoneal catheter, 36 inches, and ventricular catheter, 6.5 inches.There was a suture tied to the proximal end of the catheter.The ventricular catheter and the cardiac/peritoneal catheter met the requirements for leak, patency and tensile testing.Therefore, the nature of the complaint could not be replicated by laboratory personnel.Due to the length of the ventricular catheter returned only one test could be performed.Therefore, the standard deviation for the ventricular catheter could not be calculated.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: CSF-FLOW CONTROL SHUNT KIT BURR HOLE, 16 MM, MEDIUM PRESSURE
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 9298462
• Report Number: 2021898-2019-00403
• Device Sequence Number: 2373752
• Product Code: JXG
• UDI-Device Identifier: 00643169466340
• UDI-Public: 00643169466340
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K831678
• 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): 01/08/2020

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: 10/31/2023
• Device Model Number: 9040 E
• Device Catalogue Number: 9040 E
• Device Lot Number: E57218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2019
• Supplement Date Received by Manufacturer: 12/17/2019
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 01/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1