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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Swelling/ Edema (4577)
Date of Event	10/14/2020
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 the patient was admitted to the hospital due to "inadvertent fell down and head trauma." preoperative diagnosis was skull fracture, hydrocephalus, and cerebellar subdural hematoma.In order to reduce intracranial pressure, the patient was sent to the operating room under general anesthesia on (b)(6) 2020, to perform ventricle-ventricular abdominal shunt surgery, the operation process was smooth, the cerebrospinal fluid was drained smoothly, the intracranial pressure was reduced, and the related symptoms were improved.On (b)(6) 2020, the nurse on duty checked the skin and found that the local scalp wound around the drainage shunt tube implanted in the head showed obvious redness and swelling, but there was no exudate.The blood infection index was not obvious after recheck.In the next few days, the redness and swelling gradually increased.After a doctor's examination, the scalp wound was strengthened with local dressing, and a little hormone anti-allergic treatment was added, and the wound gradually healed.Additional information received stated that it was suspected that patient factors caused the problem, and local dressing changes had been strengthened.At present, the patient's head skin redness had been controlled, and their condition was stable.

• Brand Name: DELTA SHUNT KIT, REGULAR, PERFORMANCE LEVEL 1.5
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• MDR Report Key: 10871513
• Report Number: 2021898-2020-00341
• Device Sequence Number: 16884811
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/19/2020

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: 03/31/2023
• Device Model Number: 25132-5
• Device Catalogue Number: 25132-5
• Device Lot Number: E46268
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 11/19/2020
• 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: 57 YR
• Patient Weight: 75