MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CSF-SHUNT ASSEMBLY, CONTOURED REGULAR, HIGH; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	9046 B-H
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	07/24/2018
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 there was a small hole in the reservoir.
Additional Manufacturer Narrative
The returned valve did not meet the requirements for leak testing due to a large tear observed in the top of the distal occluder.It is unknown how or when this damage occurred.Therefore, the patency, siphon, reflux, pressure-flow and preimplantation testing were precluded due to this damage.The instructions for use that accompany the device caution that ¿care should be taken in handling the valves as silicone has a low cut and tear resistance.¿ proteinaceous debris was observed within the interior and exterior of the valve.All valves are 100% tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported that when the doctor primed the valve intra-operatively, a leak was noticed from a hole in the dome.The device had patient contact and was replaced.The patient was recovering following the procedure and there was no injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: CSF-SHUNT ASSEMBLY, CONTOURED REGULAR, HIGH
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7719180
• Report Number: 2021898-2018-00367
• Device Sequence Number: 13891738
• Product Code: JXG
• UDI-Device Identifier: 00673978249919
• UDI-Public: 00673978249919
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K831678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2018

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: 08/31/2019
• Device Model Number: 9046 B-H
• Device Catalogue Number: 9046 B-H
• Device Lot Number: D67297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Initial Date Received by Manufacturer: 07/24/2018
• Supplement Date Received by Manufacturer: 07/30/2018; 08/08/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 08/21/2018; 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 7 YR
• Patient Weight: 17