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

Model Number 42866

Device Problems Device Operates Differently Than Expected (2913); Mechanics Altered (2984)

Patient Problems Abdominal Pain (1685); Fall (1848); Fatigue (1849); Hearing Impairment (1881); Nausea (1970); Blurred Vision (2137); Visual Impairment (2138); Visual Disturbances (2140); Vomiting (2144); Headache, Lumbar Puncture (2186); Dizziness (2194); Complaint, Ill-Defined (2331); Neck Pain (2433); Neck Stiffness (2434); Ambulation Difficulties (2544)

Event Date 03/01/2017

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient via a manufacturer representative (rep).It was reported that the patient experienced unspecified symptoms that "seemed to line up with a shunt malfunction".

Manufacturer Narrative

Upon review of the additional information received, it was determined that device code c62955 and patient code c50499 no longer apply.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received that clarified the previously reported "unspecified symptoms" as daily chronic migraines (shunt migraines), falling, balance issues, vomiting, nausea, double vision, blurry vision, dizziness, abdominal pain, neck stiffness, neck pain, lethargy / fatigue, and sensitivity to sound and light.The previous shunt malfunction was also clarified as the product not reading correctly.It was thought to be set at 1.5, but showed an actual reading of 0.5.All the documentation also indicated that the shunt setting should be 0.5; it was unknown how the reading became off.The patient went to the emergency room on (b)(6) where a shunt tap was performed.The hcp checked the device's settings and noted it was way off what the documented reading should have been so the device was reset to 1.5.The patient's symptoms improved slightly.When inquired if there were any external/environmental/patient factors that may have led or contributed to the issue, it was reported that there were no known variables.

• Brand Name: STRATA II VALVE, REGULAR
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer (Section G): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 7259362
• MDR Text Key: 99915810
• Report Number: 2021898-2018-00076
• Device Sequence Number: 1
• Product Code: JXG
• UDI-Device Identifier: 00613994804648
• UDI-Public: 00613994804648
• Combination Product (y/n): N
• PMA/PMN Number: K042465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: 42866
• Device Catalogue Number: 42866
• Device Lot Number: E15851
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2018
• Date Device Manufactured: 08/23/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 28 YR
• Patient Weight: 84