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

Model Number	27302
Medical Device Problem Codes	Break (1069); Device Or Device Fragments Location Unknown (2590)
Health Effect - Clinical Codes	Death (1802); Device Embedded In Tissue or Plaque (3165)
Date of Event	10/25/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported an anesthesiologist stated that the device broke off into the patient.It was stated that the device was removed on (b)(6) 2017, and while withdrawing the catheter slowly and deliberately, the catheter snapped off prior to exiting the spinal column.It was noted that when the catheter fractured, a 12 cm segment left remaining in the patient.The patient underwent removal of the remainder of the catheter later.It was stated that the patient died on (b)(6) 2017.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported the remainder of the catheter was removed on (b)(6) 2017.The patient¿s cause of death was attributed to the following: acute respiratory distress syndrome, septic shock, acute kidney injury, and a thoracic aortic aneurysm.Per the operating room director, it was unknown if the death was thought to be related to the device.

• Brand Name: EDM LUMBAR DRAINAGE KIT
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7054719
• Report Number: 2021898-2017-00588
• Device Sequence Number: 13470063
• Product Code: GWM
• UDI-Device Identifier: 00673978246031
• UDI-Public: 00673978246031
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K802100
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2018

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: 01/31/2020
• Device Model Number: 27302
• Device Catalogue Number: 27302
• Device Lot Number: 212851309
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2017
• Supplement Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 11/22/2017
• Supplement Report FDA Received Date: 01/03/2018
• 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: Death; Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 113