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

Model Number	44420
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Staphylococcus Aureus (2058); Tachycardia (2095); Dizziness (2194); Malaise (2359)
Date of Event	09/25/2016
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 the pseudotumor patient was implanted in (b)(6) 2016.About two weeks after implant, the patient was dizzy and sick.They went to the emergency room with an elevated heart rate.The patient was admitted to the intensive care unit with (b)(6).Vancomycin was administered, and the shunt was explanted at the end of (b)(6) 2016.

• 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: 7084687
• Report Number: 2021898-2017-00628
• Device Sequence Number: 1351942
• Product Code: JXG
• UDI-Device Identifier: 00643169010796
• UDI-Public: 00643169010796
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K091312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date (Section B): 12/05/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2020
• Device Model Number: 44420
• Device Catalogue Number: 44420
• Device Lot Number: E05185
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2017
• Initial Report FDA Received Date: 12/05/2017
• 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: 55 YR
• Patient Weight: 91