MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CSF-SNAP SHUNT VENTRICULAR CATHETER; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTR

Model Number	41407
Medical Device Problem Codes	Break (1069); Fracture (1260); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report source: this event occurred in (b)(6).Device evaluated by mfr: no products have been returned to medtronic for analysis.(b)(4).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 the patient received a vp-shunt in 2018, due to the "nph" diagnosis.There is a history of clinical deterioration "since some months" and an x-ray picture showed interruption at the ventricular catheter.The product was noted to be damaged.The procedure was completed with a new product during a revision surgery.It was noted that it was unknown if any broken pieces of the product remain inside the patient's body.There was no reported impact to the patient.
Event or Problem Description
Additional information was received.Clarification determined that the shunt was not working properly and there symptoms the patient was experiencing.There were no damaged pieces left in the patients body.The issues had been occurring for 3-5 months.The doctor was unable to find anything in the patients life that would cause this issue and was unable to determine the cause of the event.
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.

• Brand Name: CSF-SNAP SHUNT VENTRICULAR CATHETER
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTR
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 5290 california ave; irvine CA 92617
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 14014530
• Report Number: 2021898-2022-00087
• Device Sequence Number: 15021370
• Product Code: LKG
• UDI-Device Identifier: 00643169472334
• UDI-Public: 00643169472334
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2022

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: 11/30/2022
• Device Model Number: 41407
• Device Catalogue Number: 41407
• Device Lot Number: E41718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2022
• Supplement Date Received by Manufacturer: 09/21/2022
• Initial Report FDA Received Date: 04/05/2022
• Supplement Report FDA Received Date: 10/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/21/2017
• 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; Hospitalization
• Patient Sex: Unknown