MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY SHUNT B-M ASSY US PER 90CM SM MED; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	22017 B-M
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2019
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 before implantation, when the valve was tested, it was not continuous.It was noted that the water column did not sink.
Additional Manufacturer Narrative
The returned device was patent.The valve met the requirements for leak, reflux, and preimplantation testing.The valve did not meet the requirements of pressure flow testing.Crystalline debris was observed on the interior of the valve.The instructions for use cautions, ¿care must be taken to ensure that particulate contaminants are not introduced into shunt components during handling.Introduction of contaminants could result in improper performance of the shunt system.¿ all valves are 100% tested at the time of manufacture.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
There are no any external factors that may have let or contributed to the issue.

• Brand Name: SHUNT B-M ASSY US PER 90CM SM MED
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8768690
• Report Number: 2021898-2019-00268
• Device Sequence Number: 1937479
• Product Code: JXG
• UDI-Device Identifier: 00643169483613
• UDI-Public: 00643169483613
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K873247
• 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): 09/11/2019

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: 09/30/2020
• Device Model Number: 22017 B-M
• Device Catalogue Number: 22017 B-M
• Device Lot Number: E03310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 08/23/2019
• Initial Report FDA Received Date: 07/08/2019
• Supplement Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1