MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CSF-FLOW CONTROL VALVE, CONTOURED REGULAR, MEDIUM PRESSURE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number	42324
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information received reported there was no allegation that the device caused or contributed to the patient¿s infection.According to the report, the patient underwent a revision on (b)(6) 2016 due to subcutaneous cerebrospinal fluid accumulation.The valve was then explanted on (b)(6) 2017 due to infection and no replacement was implanted.Reportedly, the current status indicated that during admission at the hospital, ¿auricular fibrillation was not previously recorded.¿ the patient experienced a moderate cognitive decline.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported to medtronic neurosurgery that the patient developed an infection.According to the report, the valve was replaced.Reportedly, the patient's status was alive-no injury.
Additional Manufacturer Narrative
Additional information received reported there was no allegation that the device caused or contributed to the patient¿s infection.According to the report, the patient underwent a revision on (b)(6) 2016 due to subcutaneous cerebrospinal fluid accumulation.The valve was then explanted on (b)(6) 2017 due to infection and no replacement was implanted.Reportedly, the current status indicated that during admission at the hospital, ¿auricular fibrillation was not previously recorded.¿ the patient experienced a moderate cognitive decline.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-FLOW CONTROL VALVE, CONTOURED REGULAR, 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: 6648375
• Report Number: 2021898-2017-00327
• Device Sequence Number: 13676061
• Product Code: JXG
• UDI-Device Identifier: 00643169466944
• UDI-Public: 00643169466944
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K841442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 42324
• Device Lot Number: E18254
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/19/2017
• Supplement Date Received by Manufacturer: 06/20/2017; 06/20/2017
• Initial Report FDA Received Date: 06/16/2017
• Supplement Report FDA Received Date: 07/20/2017; 09/07/2017
• 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: Hospitalization; Required Intervention