MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CSF-FLOW CONTROL VALVE, BURR HOLE, 16 MM, HIGH PRESSURE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	42546
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/21/2018
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 device was defective.There was no injury as a result of this event.The patient's status at the time of the report was alive-no injury.
Additional Manufacturer Narrative
The returned valve was patent and met the requirements for reflux and leak testing.However, the valve did not meet the requirements for pressure-flow and preimplantation testing.The valves inlet was damaged.The packaging box the valve arrived in was crushed upon receipt.It is unknown how or when this damage occurred to the valve and the packaging.The instructions for use cautions, ¿improper handling or use of instruments when implanting shunt products may result in the cutting, slitting, crushing or breaking of components.Such damage may lead to a loss of shunt integrit.¿ all valves are 100% tested 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.
Event or Problem Description
Information received indicated that the product did not have patient contact.

• Brand Name: CSF-FLOW CONTROL VALVE, BURR HOLE, 16 MM, HIGH PRESSURE
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7949177
• Report Number: 2021898-2018-00491
• Device Sequence Number: 2337931
• Product Code: JXG
• UDI-Device Identifier: 00643169466906
• UDI-Public: 00643169466906
• Combination Product (Y/N): N
• PMA/510(K) Number: K831678
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/28/2018

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: 05/31/2020
• Device Model Number: 42546
• Device Catalogue Number: 42546
• Device Lot Number: D81619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 12/28/2018; 12/28/2018
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 12/28/2018; 12/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 23 YR