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	01/05/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The returned reservoir met the requirements for leak testing.It did not meet the requirements for patency testing as the one-way valve mechanism within the reservoir was observed to be occluded.It is unknown how or when this occurred.A review of the manufacturing records showed no anomalies.A review of the manufacturing records showed no anomalies.All reservoirs are 100% tested at the time of manufacture.This medical device report is being resubmitted to the emdr system due to a connection error within the emdr system.The event was previously reported to the emdr portal and an acknowledgement 3 received, but the connection error prevented the emdr system from documenting the report.The report number in this report is the same number as the impacted report that has the connection issue.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported to medtronic neurosurgery that preoperatively, the doctor found the lumboperitoneal reservoir was occluded when tested.According to the report, the patient was implanted with a lumboperitoneal catheter and the patient¿s current status is normal.

• 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: 8722241
• Report Number: 2021898-2015-00060
• Device Sequence Number: 11194988
• 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
• Report Date (Section B): 06/21/2019

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: 11/30/2018
• Device Model Number: 44513
• Device Catalogue Number: 44513
• Device Lot Number: D50699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2015
• Initial Report FDA Received Date: 06/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 39 YR