MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY EXTERNAL DRAINAGE AND MONITORING, LUMBAR DRAINAGE KIT; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Model Number	27303
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	01/15/2019
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 was admitted to the hospital with a traumatic head and brain contusion with a small hematoma and su barachnoid hemorrhage.The patient had a severe headache, and the blood clot was abnormal after admission.On the second day, the blood coagulation was restored to normal.In order to prevent hydrocephalus from draining subarachnoid hemorrhage, the intracranial pr essure was monitored.After the communication was signed on (b)(6) 2019, the lumbar pool was drained.The puncture was placed smoothly, and the tube was kept for 3 days.The drainage of the cerebrospinal fluid was relatively clear, and the tube was extinct on (b)(6) 2019.After about 1 hour of extubation, the patient developed lumbrosacral pain.Mri examination of the lumbar vertebrae revealed a hematoma in the spinal canal (chest 12 - waist 2) which was obvious, and the conical pony tail was compressed.Hematoma absorption occurred after one week of conservative treatment.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported that the patient had recovered and been discharged from the hospital.

• Brand Name: EXTERNAL DRAINAGE AND MONITORING, LUMBAR DRAINAGE KIT
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 8404255
• Report Number: 2021898-2019-00097
• Device Sequence Number: 16726106
• Product Code: GWM
• UDI-Device Identifier: 00673978246048
• UDI-Public: 00673978246048
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K802100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2021
• Device Model Number: 27303
• Device Catalogue Number: 27303
• Device Lot Number: 210794320
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 03/08/2019
• Supplement Report FDA Received Date: 03/29/2019
• 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: Other
• Patient Age: 85 YR
• Patient Weight: 65