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U.S. Department of Health and Human Services

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

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MEDTRONIC NEUROSURGERY DELTA SHUNT KIT, REGULAR, PERFORMANCE LEVEL 1.5; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS Back to Search Results
Model Number 25132-5
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Swelling/ Edema (4577)
Event Date 10/14/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event 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.
 
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Brand Name
DELTA SHUNT KIT, REGULAR, PERFORMANCE LEVEL 1.5
Type of Device
SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
Manufacturer (Section D)
MEDTRONIC NEUROSURGERY
5290 california ave
irvine CA 92617
Manufacturer (Section G)
MEDTRONIC NEUROSURGERY
5290 california ave
irvine CA 92617
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10871513
MDR Text Key218527091
Report Number2021898-2020-00341
Device Sequence Number1
Product Code JXG
UDI-Device Identifier00643169466418
UDI-Public00643169466418
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K902783
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 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
Device Operator Health Professional
Device Expiration Date03/31/2023
Device Model Number25132-5
Device Catalogue Number25132-5
Device Lot NumberE46268
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/04/2020
Initial Date FDA Received11/19/2020
Date Device Manufactured05/04/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age57 YR
Patient Weight75
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