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

Model Number	46917
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/04/2019
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 surgeon was removing the lumbar drain catheter from the patient 3 days after implantation.There was no issue during the insertion of the implant.Prior to removal, the draining of the cerebrospinal fluid was optimal and efficient.No unusual symptoms or events occurred.However, upon removal, the surgeon encountered a slight/light resistance while pulling out the catheter.The surgeon found the catheter was broken.Approximately 8.7 cm was found to be stuck in the patient's lumbar spine.The remnant lumbar drain was visualized in one continuous segment 8.7 cm from its tip abutting the right superior corner of the l3 vertebra (next to the right l3 pedicle) through the l4/5 interspinous ligament via a left paracentral approach, to its proximal breakage point about 3 cm deep from the skin.It was noted that a subsequent x-ray was taken, and an exploratory surgery was performed to locate the broken catheter from the patient.However, they were unable to locate and remove the remaining of the implant.The patient was healthy and recovering well despite the event.

• Brand Name: DUET EXTERNAL DRAINAGE AND MONITORING SYSTEM
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 9507540
• Report Number: 2021898-2019-00451
• Device Sequence Number: 2001970
• 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: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/20/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/21/2020
• Device Model Number: 46917
• Device Catalogue Number: 46917
• Device Lot Number: 214053154
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 12/20/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 67