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

Model Number	27302
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information regarding an external lumbar drainage and monitoring system.There was a breach in the drainage tube.There was a rupture of the intracranial aneurysm with subarachnoid hemorrhage (h-h grade 4).This product was used for cerebrospinal fluid drainage.The patient was admitted to the emergency department on (b)(6) 2021 due to a ruptured intracranial aneurysm with subarachnoid hemorrhage (h-h grade 4).Due to medical conditions, at on (b)(6), in the second ward of the department of critical care medicine, under local anesthesia, an external lumbar drainage and monitoring system was used to perform lumbar cistern drainage and drainage.2% lidocaine, about 3ml, layer by layer local anesthesia at the puncture point.At first, the no.9 puncture needle of the lumbar puncture bag was inserted vertically into the skin surface of the puncture point, and the needle was inserted for about 6cm to obtain a sense of breakthrough.After pulling out the needle core, light yellow cerebrospinal fluid flowed out, and the measured intracranial pressure was about 210cmh2o.The test was negative and the process was smooth.Took 1 tube for inspection and the puncture needle was removed.Opened the external lumbar drainage and monitoring system, took out the lumbar cistern puncture needle, and slowly inserted the needle in the direction of the lumbar puncture at the same puncture point, about 5cm in the needle which could obviously feel the sense of breakthrough.And the cerebrospinal fluid could be seen flowing out after removing the needle core.The drainage tube of the lumbar cistern was taken and the guide wire was inserted into the drainage tube.The drainage tube was inserted into the spinal canal about 14 cm.The puncture needle and guide wire were removed.No cerebrospinal fluid outflow was seen.After removing the drainage tube and inserting the guide wire again, it was found that there was a breach 5cm away from the drainage tube.Measurement were taken and immediately after the site gave the patient another set of external lumbar drainage and monitoring system, and slowly inserted the needle in the direction of lumbar puncture at the same puncture point.A sense of breakthrough could be clearly felt when the needle was inserted about 5cm, the cerebrospinal fluid could be seen flowing out after the needle core was removed.The drainage tube of lumbar cistern was taken out for examination, and no abnormality was found.Took the drainage tube of the lumbar cistern and placed it into the spinal canal about 14cm.After removing the puncture needle, fixed the drainage tube and connected the bag.There was no impact on the patient.During the operation, the patient's vital signs were stable, the operation process was smooth, and there were no adverse reactions.The patient was given bed rest for 6 hours, and the craniocerebral vital signs were observed.Preliminary action that were given were immediately used another set of lumbar external drainage and monitoring system for re-puncture and drainage.
Event or Problem Description
Additional information received reported there were no environmental/external/patient factors that may have led or contributed to the issue.
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: 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: 12738775
• Report Number: 9612164-2021-04176
• Device Sequence Number: 4126706
• Product Code: GWM
• UDI-Device Identifier: 00763000343194
• UDI-Public: 00763000343194
• 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,Followup
• Report Date (Section B): 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/02/2024
• Device Model Number: 27302
• Device Catalogue Number: 27302
• Device Lot Number: 221613876
• 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: 10/14/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 11/19/2021
• Date Device Manufactured: 02/03/2021
• 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
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 65 KG