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

Model Number	27303
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during the operation, the physician found that cerebrospinal fluid did not flow out of the catheter and that the lumbar external drainage and monitoring system catheter was impassable after lumbar puncture.There were no reports of patient injury in association with this event.After the event, the physician changed the device with the same model in time, which did not have a great impact on the patient.
Additional Manufacturer Narrative
The returned product was connected to an empty syringe.31.5 inches of the catheter was returned.The device could not be tested for leak testing and did not meet the requirements for patency due to occlusion of the catheter.There was proteinaceous debris observed on the interior and exterior of the device.Due to the amount of proteinaceous debris on the catheter, tensile testing could not be performed.If information is provided in the future, a supplemental report will be issued.

• 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: 8395335
• Report Number: 2021898-2019-00089
• Device Sequence Number: 13788379
• 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): 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 27303
• Device Catalogue Number: 27303
• Device Lot Number: 210965097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2019
• Supplement Date Received by Manufacturer: 03/20/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Weight: 70