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

Model Number	27824
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	Headache (1880)
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 patient was experiencing headaches.The patient¿s status was noted as 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 the peritoneal catheter was blocked.
Additional Manufacturer Narrative
Additional information received clarified the previously reported information regarding a blocked catheter did not pertain to this event.This information pertained to the event captured in regulatory report #2021898-2017-00642.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received reported the headaches were due to intracranial pressure and not the device.It was stated the patient was doing fine and had a new shunt implanted.No further information was provided.

• Brand Name: STRATA II UNITIZED SHUNT, SMALL, 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: 7108329
• Report Number: 2021898-2017-00641
• Device Sequence Number: 19105349
• Product Code: JXG
• UDI-Device Identifier: 00643169010444
• UDI-Public: 00643169010444
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,Followup,Followup
• Report Date (Section B): 05/25/2018

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: 10/31/2019
• Device Model Number: 27824
• Device Catalogue Number: 27824
• Device Lot Number: E19175
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2017
• Supplement Date Received by Manufacturer: 04/05/2018; 05/17/2018
• Initial Report FDA Received Date: 12/12/2017
• Supplement Report FDA Received Date: 05/02/2018; 05/25/2018
• 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
• Patient Weight: 89