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

Model Number	27302
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	Malaise (2359)
Date of Event	06/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information regarding an external drainage and monitoring system.It was reported that the patient was admitted to the hospital with the main complaint of "blurred vision in both eyes for more than 2 years and paroxysmal headache for more than 1 year".On (b)(6) 2024, the patient was sent to the operating room for "transsphenoidal approach sellar skull base tumor resection under neuronavigation + neuroendoscopy-assisted ventricular choroid plexus cauterization + optic nerve decompression + sellar dura mater repair + right thigh fascia lata resection" under general anesthesia with tracheal intubation.In order to prevent cerebrospinal fluid leakage during operation, lumbar external drainage and monitoring system was retained.On the evening of june 9,2024, when the nurse was patrolling the ward to check the pipeline, it was found that the dressing at the lumbar cistern was loose, and there was cerebrospinal fluid leakage.After inspection, it was found that the drainage tube was broken at 15 cm of the outer pipeline of the skin puncture outlet, the dressing covering the puncture outlet was moist, and the nursing pad placed on the lumbar sacral region had obvious signs of cerebrospinal fluid outflow and moisture.The patient did not turn over or get agitated, and it was broken when it was discovered.After checking, the doctor strictly disinfected the 15 cm exposed long pipelinewhich remained at the lumbar puncture and pulled it out, and the surgical incision was covered with sterile dressings after suturing.The lumbar cistern drainage device was re-placed on (b)(6) 2024.The patient was currently in poor spirits, with a temperature of 36.5, a pulse of 82 beats/min, and a respiration of 18 breaths/min.After the lumbar cistern drainage tube was broken, continued cerebrospinal fluid leakage may lead to intracranial infection.Paid attention to rechecking cerebrospinal fluid biochemistry and culture, and regularly monitor to prevent the occurrence of intracranial infection.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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: 19577155
• Report Number: 9612164-2024-02929
• Device Sequence Number: 8524952
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/20/2024

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: 01/22/2026
• Device Model Number: 27302
• Device Catalogue Number: 27302
• Device Lot Number: 225969211
• 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: 06/19/2024
• Initial Report FDA Received Date: 06/20/2024
• Date Device Manufactured: 02/22/2023
• 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 Age: 37 YR
• Patient Sex: Male