MAUDE Adverse Event Report: MEDTRONIC MEXICO EDM LUMBAR DRAINAGE KIT; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Model Number	27302
Medical Device Problem Codes	Break (1069); Fracture (1260); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	05/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3) no parts have been returned for analysis.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.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
Medtronic received information regarding a catheter.It was reported that the anterior segment of the catheter ruptured, and insertion was difficult.The patient underwent lumbar cistern drainage under local anesthesia on (b)(6) 2023.Took the right side chest and knee position.Took the intersection of the line connecting the posterior superior iliac spine and the posterior midline as the puncture point.The intersection of the connecting line of the posterior superior iliac spine and the posterior midline was taken as the puncture point.Conventional disinfection towel laying.After 2% lidocaine was anesthetized layer by layer, puncture needle was used instead.Bloody cerebrospinal fluid flowed out after successful puncture.Difficulty in implanting drainage catheter, repeated adjustments, insertion of catheter.After removing the catheter, connected the drainage device.Checked the patency of the catheter, no cerebrospinal fluid flow out of the catheter.The catheter was checked, the puncture catheter was pulled out, and it was planned to be reinserted, but the anterior segment of the catheter was broken.Puncture again, after successful puncture, catheter placement was still difficult.Considering that there was more cerebrospinal fluid outflow, the success rate of re-puncture or intubation after puncture was low.Abandoned this puncture, and the puncture failed.After the operation, informed the patient's family of the specific situation, and the family members expressed their understanding and chose to be conservative and not remove it.No harm ha s been done to the patient.The facility reported that the catheter may have been entrapped during the puncture, and the puncture needle cut the drainage tube.

• Brand Name: EDM LUMBAR DRAINAGE KIT
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 17321279
• Report Number: 9612164-2023-03173
• Device Sequence Number: 6488710
• Product Code: GWM
• UDI-Device Identifier: 00763000406080
• UDI-Public: 00763000406080
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K984053
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2023

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 Expiration Date: 11/03/2024
• Device Model Number: 27302
• Device Catalogue Number: 27302
• Device Lot Number: 223388608
• 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: 06/25/2023
• Initial Report FDA Received Date: 07/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/06/2021
• 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 Sex: Unknown