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

Model Number 25132-5

Device Problem Disconnection (1171)

Patient Problem Swelling (2091)

Event Date 07/08/2019

Event Type  Injury  

Manufacturer Narrative

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

Event 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
• 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: 8871964
• MDR Text Key: 153667261
• Report Number: 2021898-2019-00310
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00643169466418
• UDI-Public: 00643169466418
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K902783
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/04/2018
• 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): Required Intervention
• Patient Age: 54 YR