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

Model Number	42312
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Erosion (1750)
Date of Event	05/01/2017
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
It was reported that on (b)(6) 2017, the patient's parents contacted the doctor because they noticed would break down at the shunt site with exposure of the shunt tubing.It was noted as protruding from their scalp.The doctor advised removal of the shunt due to the high risk of infection from an exposed shunt.On (b)(6) 2017, the patient's shunt was removed and replaced with an external ventricular drain (evd).On (b)(6) 2017, after 3 days of negative cultures to confirm no infection, the evd was removed, and a shunt was implanted.
Additional Manufacturer Narrative
Previous reported information no longer applies.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during the patient's may admission for chemotherapy, their shunt tubing was visible, and there was wound dehiscence.On (b)(6) 2017, the patient's doctors attempted to suture it by closing the wound with nylon suture, bacitracin, and antibiotics were given.Due to wound healing problems and infection as a result of the immunocompromised state of an infant on chemotherapy, that proved unsuccessful.On (b)(6) 2017, the patient was admitted to revise their shunt due to further shunt complications.The shunt was tapped at the patient's bedside.On (b)(6), the doctor removed their shunt, debrided their scalp tissue, and placed an external ventricular drain (evd).On (b)(6) 2017, the doctor placed a new shunt at another location on the other side of the patient's head.

• Brand Name: CSF-FLOW CONTROL VALVE, CONTOURED SMALL, LOW
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8634039
• Report Number: 2021898-2019-00190
• Device Sequence Number: 1857719
• Product Code: JXG
• UDI-Device Identifier: 00643169466494
• UDI-Public: 00643169466494
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K841442
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: 42312
• Device Catalogue Number: 42312
• Device Lot Number: D81411
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2019
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 05/22/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 8 MO