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

Catalog Number	9040 E
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was unavailable for return.Therefore an evaluation of the device performance was not possible.A review of the manufacturing records showed no anomalies.All valves are 100% tested at the time of manufacture.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported to medtronic neurosurgery that when the healthcare professional flushed the valve preoperatively, it was not working.According to the report, the inlet valve only would suck the normal saline but could not flush.Reportedly, there was no injury to the patient.
Additional Manufacturer Narrative
Only the peritoneal catheter was returned.Approximately 90 cm of the peritoneal catheter was returned.The catheter was patent and met the requirements for leak testing.A review of the manufacturing records showed no anomalies.All catheters are 100% inspected at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: CSF SHUNT KIT, BURR HOLE VALVE, 16MM, MEDIUM
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6527815
• Report Number: 2021898-2017-00231
• Device Sequence Number: 11177343
• Product Code: JXG
• UDI-Device Identifier: 00643169466340
• UDI-Public: 00643169466340
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/28/2017

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: 03/31/2021
• Device Catalogue Number: 9040 E
• Device Lot Number: E11990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Initial Date Received by Manufacturer: 03/28/2017
• Supplement Date Received by Manufacturer: Not provided; 05/30/2017
• Initial Report FDA Received Date: 04/27/2017
• Supplement Report FDA Received Date: 06/29/2017; 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1