MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CSF-FLOW CONTROL SHUNT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	9040 E
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
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 the peritoneal catheter broke when the doctor pulled up and wanted to connect to the valve.The doctor changed the catheter from a csf flow control shunt kit as well as a burr hole shunt kit; however, the peritoneal catheters broke too.The doctor used another new peritoneal catheter, and it worked.As a result, the procedure was delayed 2 hours.The patient's status at the time of the report was alive-no injury.

• Brand Name: CSF-FLOW CONTROL SHUNT
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• MDR Report Key: 12367361
• Report Number: 2021898-2021-00153
• Device Sequence Number: 11863862
• Product Code: JXG
• UDI-Device Identifier: 00643169466340
• UDI-Public: 00643169466340
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K831678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2021

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: 03/31/2024
• Device Model Number: 9040 E
• Device Catalogue Number: 9040 E
• Device Lot Number: E65310
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2021
• Initial Report FDA Received Date: 08/25/2021
• 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