MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA NSC LUMBOPERITONEAL SHUNT KIT; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	44421
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Bacterial Infection (1735); Hepatitis (1897); No Known Impact Or Consequence To Patient (2692)
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 a lumbar-peritoneal shunt procedure was performed using the valve and catheter.After that, as there was a possibility of infection, the valve and catheter were removed from the patient's body due to being occluded.It was noted that during the procedure, the abdominal catheter was outside of the aseptic field so another abdominal catheter was used instead.It was stated that the whole system was removed.Additional information received reported that the patient's infection was (b)(6) and bacillus cereus.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported the cause of the infections was unknown, however it was noted the infections were not related to the device.The patient underwent an implant of a ventriculoperitoneal shunt in late (b)(6) 2018.The patient¿s status was good.

• Brand Name: STRATA NSC LUMBOPERITONEAL SHUNT KIT
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7060638
• Report Number: 2021898-2017-00590
• Device Sequence Number: 16458718
• Product Code: JXG
• UDI-Device Identifier: 00643169010789
• UDI-Public: 00643169010789
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2018

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: 01/31/2022
• Device Model Number: 44421
• Device Catalogue Number: 44421
• Device Lot Number: E27073
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2017
• Supplement Date Received by Manufacturer: 01/31/2018
• Initial Report FDA Received Date: 11/27/2017
• Supplement Report FDA Received Date: 02/28/2018
• 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