MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CSF ULTRA SMALL VALVE, MEDIUM PRESSURE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	42414
Medical Device Problem Codes	Break (1069); Fracture (1260); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the csf would not flow into the valve due to it being blocked/damaged, which the physicians assumed to be due to a product failure.As a result the device was replaced.No pieces remained inside the patient's body.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported the patient was alive and good.It was noted the valve was bathed in sodium chloride prior to implantation.

• Brand Name: CSF ULTRA SMALL VALVE, MEDIUM PRESSURE
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8436369
• Report Number: 2021898-2019-00116
• Device Sequence Number: 277334
• Product Code: JXG
• UDI-Device Identifier: 00643169466081
• UDI-Public: 00643169466081
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: K873247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 42414
• Device Catalogue Number: 42414
• Device Lot Number: E42260
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2019
• Supplement Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 05/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention