MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY EDM VENTRICULAR CATHETER, LARGE DIAMETER, 35 CM; DEVICE, MONITORING, INTRACRANIAL PRESSURE

Model Number	27703
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930)
Date of Event	10/16/2019
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
Additional information received reported there were no environmental/external/patient factors that may have led or contributed to the issue.
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) 2019, the patient underwent surgery for an external monitoring and drainage system.On (b)(6) 2019, the patient's family found a rupture at the connection joint of the ventricular catheter.It was stated there was also cerebrospinal fluid leakage.The doctor promptly extubated it and disposed of the catheter.The patient developed a fever and intracranial infection that day.After more than 10 days of treatment to control the infection, the patient was discharged on (b)(6) 2019.

• Brand Name: EDM VENTRICULAR CATHETER, LARGE DIAMETER, 35 CM
• Common Device Name: DEVICE, MONITORING, INTRACRANIAL PRESSURE
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 9476281
• Report Number: 2021898-2019-00439
• Device Sequence Number: 2903205
• Product Code: GWM
• UDI-Device Identifier: 00643169496880
• UDI-Public: 00643169496880
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K984053
• 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,Followup
• Report Date (Section B): 01/08/2020

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: 04/30/2023
• Device Model Number: 27703
• Device Catalogue Number: 27703
• Device Lot Number: E46562
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 12/20/2019
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 01/08/2020
• 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
• Patient Age: 64 YR