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

Model Number	46917
Medical Device Problem Codes	Fracture (1260); Device Or Device Fragments Location Unknown (2590); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Swelling (2091); Device Embedded In Tissue or Plaque (3165)
Date of Event	04/16/2018
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 had a lumbar drain done on (b)(6) 2018.The following day, the surgeon was to remove the catheter as there was no drainage and the patient had swelling on the brain.Resistance was felt during the removal and as the surgeon was pulling, the catheter broke into two pieces.A portion was left in the subarachnoid space.An operation to remove the piece was done, but was unsuccessful.The surgeon performed a laminectomy at l4-l5, but the broken piece was floating within the space.A second drain was inserted, and the patient¿s status was listed as alive ¿ no injury.
Additional Manufacturer Narrative
The returned duet was patent and met requirements for leak testing.Approximately 60 cm of the lumbar catheter was returned.The device did not meet the patency requirements.There was proteinaceous debris observed within the interior and exterior of the catheter.Leak testing could not be completed due to the catheter occlusion.All catheters are 100% inspected at the time of manufacture.If information is provided in the future, a supplemental report will be issued.

• 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: 7451891
• Report Number: 2021898-2018-00212
• Device Sequence Number: 1233236
• 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
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2018

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: 03/31/2020
• Device Model Number: 46917
• Device Catalogue Number: 46917
• Device Lot Number: 213170699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2018
• Supplement Date Received by Manufacturer: 05/17/2018
• Initial Report FDA Received Date: 04/23/2018
• Supplement Report FDA Received Date: 05/17/2018
• 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: Hospitalization; Required Intervention
• Patient Age: 20 YR