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	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received information regarding a drainage tube.On (b)(6) 2021 the patient underwent brainstem tumor resection due to a brainstem tumor.On (b)(6) 2021 the drainage tube was removed, and it was decided to perform lumbar cistern drainage tube implantation.First the site used it between l3 and 4, and used the no.9 lumbar puncture package to successfully puncture, and recorded the depth of the puncture needle.Then, they followed the instructions of medtronic lumbar drainage kit, and used the puncture needle (thicker, about 1mm in diameter) in the kit to puncture into the subarachnoid space.On the opposite side of the needle port, they inserted the guide wire into the drainage tube of the lumbar cistern.Then inserted the drainage tube with the guide wire through the puncture needle into the subarachnoid space about 8cm.They removed the guide wire and it was not smooth, and the drainage of the cerebrospinal fluid was not smooth after removal.It was planned to puncture the catheter again, and after removing the catheter, it was found that there was a fracture.An emergency ct scan revealed that some of the catheter's broken ends remained in the spinal canal, entwining the cauda equina nerve.Removal of the foreign body in the spinal canal was performed in the emergency department at 3:00pm, and the broken end was removed during the surgery.The measurement showed that the catheter broke from 8cm, and there was a 2cm tear section, a total of 10cm.It was considered that the guide wire made the catheter hard, and the angle with the puncture needle was large, which was difficult to remove, and caused the catheter to be cut by the puncture needle.As a result, the indwelling part of the drainage tube was in the subarachnoid space in the spinal canal and needed to be removed surgically.Additional information received reported that the patient had recovered, and there was no permanent damage.
Additional Manufacturer Narrative
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: 12852311
• Report Number: 9612164-2021-04508
• Device Sequence Number: 4005765
• 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
• Report Date (Section B): 11/22/2021

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: 12/26/2023
• Device Model Number: 27302
• Device Catalogue Number: 27302
• Device Lot Number: 221589959
• 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: 11/12/2021
• Initial Report FDA Received Date: 11/22/2021
• Date Device Manufactured: 01/26/2021
• 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; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 75 KG