MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CSF-SHUNT ASMBLY, SM., MED. PRESS. W/ C/P CATH, SM, 90CM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	46624
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/13/2020
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 when the device was pre-tested by running fluid through it, the healthcare professional thought there was a blockage.There was no patient impact.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported there were no environmental/external/patient factors that may have led or contributed to the issue.
Additional Manufacturer Narrative
The returned device was patent.The valve passed leakage, reflux and preimplantation testing.The valve did not pass pressure flow testing.Visual examination indicates presence of air bubbles inside the silicone material of the valve.However, since the valve was patent and met the pre-implantation testing requirement, it cannot be concluded if the presence of the air bubbles contributed towards the reported failure of blockage in the valve.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CSF-SHUNT ASMBLY, SM., MED. PRESS. W/ C/P CATH, SM, 90CM
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 9633141
• Report Number: 2021898-2020-00047
• Device Sequence Number: 3141664
• Product Code: JXG
• UDI-Device Identifier: 00643169472457
• UDI-Public: 00643169472457
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K841442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2020

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: 05/31/2021
• Device Model Number: 46624
• Device Catalogue Number: 46624
• Device Lot Number: E12959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Initial Date Received by Manufacturer: 01/24/2020
• Supplement Date Received by Manufacturer: 01/27/2020; 04/20/2020
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 02/03/2020; 04/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1