MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY STRATAMR VALVE, REGULAR; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS

Model Number	42965
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Codes	Extreme Exhaustion (1843); Headache (1880); Nausea (1970); Blurred Vision (2137); Visual Impairment (2138); Vomiting (2144); Ambulation or Postural Difficulties (2544)
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 in the hospital 4 times since she was implanted with a shunt on (b)(6) 2016.The reason for the hospitalization was noted as shunt failure.The patient experienced nausea, vomiting, headaches, blurred vision, double vision, unsteady gait, and extreme fatigue related to the previously noted shunt failure.The patient had her valve adjusted to a setting of 2.5, but reported that she does not feel any better than when it was at a lower setting.The patient has an appointment with her health care provider (hcp) on (b)(6) 2018 to potentially readjust the valve to another setting.The patient's medical history includes a brain tumor on her brain stem, which is the reason for the shunt implantation.

• Brand Name: STRATAMR VALVE, REGULAR
• Common Device Name: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 7276503
• Report Number: 2021898-2018-00088
• Device Sequence Number: 2273745
• Product Code: JXG
• UDI-Device Identifier: 00643169692701
• UDI-Public: 00643169692701
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152700
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Patient
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 02/16/2018

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: 09/30/2017
• Device Model Number: 42965
• Device Catalogue Number: 42965
• Device Lot Number: E12041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2018
• Initial Report FDA Received Date: 02/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1702-2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization