MAUDE Adverse Event Report: MEDTRONIC MEXICO EXTERNAL DRAINAGE AND MONITORING, 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	11/21/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient underwent external drainage of cerebrospinal fluid after resection of a glioma recurrence.The doctor placed a drainage tube in the lumbar cistern of the patient on (b)(6) 2020, and on (b)(6) 2020, the nurse checked that the tube was properly fixed, and the drainage flow was smooth.However, later that night, the nurse found that the patient's bed sheets were wet, and the drainage tube was found to be broken after further examination.The nurse immediately turned the stump of the drainage tube on the patient's side when the broken tube was found and reported to the doctor on duty.The doctor pulled out the drainage tube at the bedside and asked to pay close attention to changes in the patient's condition.

• Brand Name: EXTERNAL DRAINAGE AND MONITORING, 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
• MDR Report Key: 11140746
• Report Number: 9612164-2021-00099
• Device Sequence Number: 676962
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2021

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: 07/17/2023
• Device Model Number: 27302
• Device Catalogue Number: 27302
• Device Lot Number: 220564309
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 01/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR