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

Model Number 42312

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Erosion (1750)

Event Date 05/01/2017

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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.

Manufacturer Narrative

Previous reported information no longer applies.If information is provided in the future, a supplemental report will be issued.

Event 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
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8634039
• MDR Text Key: 145861191
• Report Number: 2021898-2019-00190
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00643169466494
• UDI-Public: 00643169466494
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K841442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/15/2019
• Initial Date FDA Received: 05/22/2019
• Supplement Dates Manufacturer Received: 05/15/2019
• Supplement Dates FDA Received: 05/22/2019
• Date Device Manufactured: 06/17/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 8 MO