MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY DELTA SHUNT KIT, REGULAR, PERFORMANCE LEVEL 1.5; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	25132-5
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Swelling (2091)
Date of Event	07/08/2019
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 shunt tube was detached.It was reported that the patient was admitted to the operating room under the general anesthesia for endoscopic ventriculo-peritoneal shunt + ventricular choroid plexus cauterization + intracranial decompression; intraoperative successful puncture of the right ventricle frontal angle.The brain pressure was slightly high, the cerebrospinal fluid was colorless and clear, and the shunt device was connected.The abdominal cavity end was placed under the xiphoid process about 30 cm, and the whole process was smooth.Next day, the physician saw that the shunt valve was pressed smoothly, and the head drainage tube was unobstructed.On (b)(6) 2019, the doctor found that the diverting valve press could touch the subcutaneous swelling, the tracheotomy sleeve was unobstructed, and the valve shunt tube was detached.The exploring emergency surgery was planned to perform, and the family members was explained the condition and the family members signed the consent to the surgical exploration and arranged the operation.On (b)(6) 2019, the patient was sent to the operating room.Under the general anesthesia, the patient underwent ventriculo-peritoneal shunt exploration.The do ctor found that the adjustable shunt tube failed and the valve was replaced, the connection was fixed, the hemostasis was fully stopped, and the subcutaneous skin was sutured in turn.

• Brand Name: DELTA SHUNT KIT, REGULAR, PERFORMANCE LEVEL 1.5
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8871964
• Report Number: 2021898-2019-00310
• Device Sequence Number: 514390
• Product Code: JXG
• UDI-Device Identifier: 00643169466418
• UDI-Public: 00643169466418
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K902783
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/07/2019

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: 03/31/2023
• Device Model Number: 25132-5
• Device Catalogue Number: 25132-5
• Device Lot Number: E46049
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2019
• Initial Report FDA Received Date: 08/07/2019
• 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
• Patient Age: 54 YR