MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CSF-LUMBOPERITONEAL RESERVOIR, 20 MM; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	44513
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	05/28/2018
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 the physician was going to do an abdominal cavity shunt operation; however, the reservoir was found to be plugged during the pre-operation test.
Additional Manufacturer Narrative
The returned reservoir was patent, and met the requirements for leak testing.Therefore, the conditions of the complaint could not be duplicated by laboratory personnel.The instructions for use that accompanied the device indicate that to perform the patency check: place the inlet connector of the reservoir into sterile isotonic fluid (e.G., physiological saline); depress the reservoir dome; place a finger over the opening of the outlet connector; release the depressed dome.If fluid enters the reservoir, the one-way miter valve and inlet connector are patent; remove the finger from the outlet connector opening and repeat the above steps until the reservoir is full; when the reservoir is full, depress the reservoir dome.If fluid flows freely out of the outlet connector, the reservoir is patent.All reservoirs are 100% tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CSF-LUMBOPERITONEAL RESERVOIR, 20 MM
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7554949
• Report Number: 2021898-2018-00273
• Device Sequence Number: 11092227
• Product Code: JXG
• UDI-Device Identifier: 00673978228471
• UDI-Public: 00673978228471
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K831396
• 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): 08/13/2018

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: 04/30/2019
• Device Model Number: 44513
• Device Catalogue Number: 44513
• Device Lot Number: D57109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2018
• Supplement Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 08/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1