MAUDE Adverse Event Report: COVIDIEN LLC CARDIAC/PERITONEAL CATHETER; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	43103
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Inflammation (1932); Unspecified Tissue Injury (4559); Swelling/ Edema (4577)
Date of Event	06/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3) no parts have been returned for analysis.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding a catheter.It was reported that a valve was recently implanted in a patient with hydrocephalus.The initial outcome was promising, as the patient experienced a resolution of hydrocephalus symptoms and overall improvement in her well-being.However, after a certain period, an edema was observed around the ventricular catheter.Due to this concerning development, further investigations were conducted, including analyses to check for signs of infection.Surprisingly, no evidence of infection was found, ruling out an infectious etiology.Nonetheless, the patient began to experience abdominal pain, prompting a repeat mri examination.The results revealed the presence of edema along the peritoneal catheter, indicating a potential complication related to the valve or catheter system.In light of the patient's deteriorating condition, the doctor made the decision to remove both the valve and catheters.Remarkably, the edema disappeared following the removal of the implant, providing relief to the patient.The doctor is currently conducting a comprehensive evaluation of the patient and willsoon provide us with a detailed report regarding his findings.
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported that on july 6, 2023, the patient presented with fever and abdominal pain.Clinical examination showed signs of inflammation on the abdominal surgical scar.A brain and thoracoabdominal ct scan were performed.A cell blood count and inflammatory blood tests showed hyper eosinophilia.Lumbar puncture was performed showing no signs of meningitis.Skin hypersensitivity tests were not performed.Brain ct scan showed good placement of the ventricular drain and hypodensity on the parenchyma surrounding its path.Thoraco-abdominal ct scan showed bilateral pleural effusion more marked on the right side with pulmonary condensation.Parietal thickening of the right colic angle surrounding the path of the abdominal peritoneal catheter with an infiltration of the surrounding fat.On (b)(6) 2023, vp shunt removal was performed.Instant postoperative improvement of the symptoms with total relief of the pain and lasting apyrexia.The surgical scars (cranial and abdominal) showed no signs of inflammation.Postoperative ct scan showed the disappearance of the hypodensity.Skin hypersensitivity tests were not performed.

• Brand Name: CARDIAC/PERITONEAL CATHETER
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer (Section G): COVIDIEN LLC; 15 hampshire street; mansfield 02048
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 17259737
• Report Number: 9612501-2023-01117
• Device Sequence Number: 5960301
• Product Code: JXG
• UDI-Device Identifier: 00613994800688
• UDI-Public: 00613994800688
• Combination Product (Y/N): N
• Initial Reporter Country: TS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2023

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 Model Number: 43103
• Device Catalogue Number: 43103
• Device Lot Number: 43103
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2023
• Supplement Date Received by Manufacturer: 09/22/2023
• Initial Report FDA Received Date: 07/05/2023
• Supplement Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female