MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATA II SHUNT ASSEMBLY, REGULAR, WITH BIOGLIDE; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	27819
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Therapeutic Effects, Unexpected (2099)
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 the patient was implanted with a shunt system, but the shunt effect was poor.It was stated that the patient's cerebrospinal fluid situation did not improve after the shunt was implanted.There were no environmental/external/patient factors that may have led or contributed to the issue.The shunt system was replaced with a new one.The patient's status at the time of the report was alive - no injury.

• Brand Name: STRATA II SHUNT ASSEMBLY, REGULAR, WITH BIOGLIDE
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 9898156
• Report Number: 2021898-2020-00110
• Device Sequence Number: 2238349
• Product Code: JXG
• UDI-Device Identifier: 00643169975637
• UDI-Public: 00643169975637
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K042465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/30/2020

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: 06/30/2022
• Device Model Number: 27819
• Device Catalogue Number: 27819
• Device Lot Number: E70404
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 03/30/2020
• 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: 39 YR