MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY CSF-VENTRICULAR PORT,16 MM, SIDE INLET CONNECTOR; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Catalog Number	44010
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was unavailable for return.Therefore an evaluation of the device performance was not possible.A review of the manufacturing records showed no anomalies.All valves are 100% tested at the time of manufacture.
Event or Problem Description
It was reported to medtronic neurosurgery that the device was leaking intra-operatively, so they stopped using the device immediately.According to the report, the device was replaced and there was no injury to the patient.
Additional Manufacturer Narrative
The returned port met the requirements for leak testing.There was proteinaceous debris observed within the interior and exterior of the port.The returned catheter was patent and met the requirements for leak testing.Proteinaceous debris was observed within the interior and exterior of the catheter.A review of the manufacturing records showed no anomalies.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.
Additional Manufacturer Narrative
Patient weight and initial reporter section updated.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CSF-VENTRICULAR PORT,16 MM, SIDE INLET CONNECTOR
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6777525
• Report Number: 2021898-2017-00431
• Device Sequence Number: 1157726
• Product Code: JXG
• 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: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/11/2017

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: 07/31/2021
• Device Catalogue Number: 44010
• Device Lot Number: E16573
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2017
• Supplement Date Received by Manufacturer: 09/06/2017; 10/08/2017
• Initial Report FDA Received Date: 08/09/2017
• Supplement Report FDA Received Date: 10/06/2017; 10/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 55