MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CSF VENTRICULAR PORT, 16 MM, SIDE INLET; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVENTRICULAR

Model Number	44010
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	04/01/2018
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 the surgeon was performing a tumor resection for the patient, and during the operation, they found that the device couldn't drain cerebrospinal fluid normally.It was stated that the surgeon immediately replaced the device with another one.The patient's status at the time of the report was alive-no 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 that the doctor confirmed that the product was unable to drain cerebrospinal fluid properly.The doctor thought the product quality problem led to the cerebrospinal fluid not being able to outflow.
Additional Manufacturer Narrative
The returned port met the requirements for leak testing.Proteinaceous debris was observed within the interior and exterior of the valve.Approximately 23 cm of the returned catheter was patent and met the requirements for leak testing.All ports and catheters are 100% inspected at the time of manufacture.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CSF VENTRICULAR PORT, 16 MM, SIDE INLET
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVENTRICULAR
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7400719
• Report Number: 2021898-2018-00182
• Device Sequence Number: 19200203
• Product Code: LKG
• UDI-Device Identifier: 00643169497108
• UDI-Public: 00643169497108
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K874468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/15/2018

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: 10/31/2021
• Device Model Number: 44010
• Device Catalogue Number: 44010
• Device Lot Number: E22922
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2018
• Supplement Date Received by Manufacturer: 04/22/2018; 05/15/2018
• Initial Report FDA Received Date: 04/05/2018
• Supplement Report FDA Received Date: 05/01/2018; 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 58