MAUDE Adverse Event Report: MEDTRONIC MEXICO DUET EXTERNAL DRAINAGE AND MONITORING SYSTEM; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Model Number	46917
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/03/2020
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 on (b)(6) 2020, the patient was admitted for right otorrhea for repair, insertion of the lumbar drain, and exploration of sphenoid sinus under a neurosurgeon and ent surgeon.On (b)(6) 2020, septoplasty and endoscopy sphenoidotomy were performed and ended uneventfully.The lumbar drain was inserted for continuous monitoring of the cerebrospinal fluid leak.On (b)(6) 2020, the neurosurgeon removed the lumbar drain at the patient's bed side with assistance from a nurse.During removal, the lumbar drain fractured.Ct of the lumbar spine showed the fractured end of the retained drain was in the subcutaneous tissue extending into the intra-dural space.There was no intra-thecal hemorrhage.On september 4, 2020, the patient underwent the removal of the fractured lumbar drain.The procedure ended uneventfully.The patient was discharged and was well on (b)(6) 2020.

• Brand Name: DUET EXTERNAL DRAINAGE AND MONITORING SYSTEM
• 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: 10743107
• Report Number: 9612164-2020-04095
• Device Sequence Number: 16990671
• Product Code: GWM
• UDI-Device Identifier: 00613994445407
• UDI-Public: 00613994445407
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K983799
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/27/2020

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: 08/01/2022
• Device Model Number: 46917
• Device Catalogue Number: 46917
• Device Lot Number: 218192555
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 10/27/2020
• 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: Hospitalization; Required Intervention