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

Model Number UNKNOWN-S

Device Problem Mechanics Altered (2984)

Patient Problems Vomiting (2144); Therapeutic Response, Decreased (2271); Malaise (2359); Numbness (2415)

Event Date 06/04/2012

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient had a condition of pseudotumor cerebri and was implanted with the device on (b)(6) 2012.The device was set to 2.5.Shortly after the surgery, the patient went back to the hospital due to symptoms.The healthcare professional (hcp) x-rayed the device and found that it was not set at 2.5.The clinicians set it back to 2.5 and the patient went home.Then in (b)(6) 2014, the patient became very ill, vomiting, and numbness.They went to the emergency room at the hospital where the hcp ran a shunt series.They found the device to be set at 0.5 and set it back to 2.5.One week later after being sent home, the patient was violently ill again, and they went back to the emergency room.The x-ray confirmed the device had moved to 1.0.The hcp concluded that the device was the issue so it was replaced with another device and set to 2.5 on (b)(6) 2016.It was noted the patient had not had any magnet resonance imaging (mri).

• Brand Name: UNKNOWN STRATA VALVE/SHUNT
• 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: 7454488
• MDR Text Key: 106291429
• Report Number: 2021898-2018-00218
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN-S
• Device Catalogue Number: UNKNOWN-S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 26 YR