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

Model Number UNKNOWN-S

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Fatigue (1849); Discomfort (2330); Complaint, Ill-Defined (2331); Patient Problem/Medical Problem (2688); No Code Available (3191)

Event Date 07/20/2018

Event Type  malfunction  

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 concussion back in february and didn't get a ct scan done until months later.The patient recently had a ct scan, and the nurse called regarding the findings, and the scan showed that their ventricles were "small." it was noted that one ventricle was smaller than before.The valve pressure hadn't changed and was set at pl 1.5.The patient was seeing the surgeon next week.The office staff told them the valve may be turned up to pl 2.0.

Manufacturer Narrative

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

Event Description

Additional information received reported the device was implanted due to the patient having hydrocephalus.They didn't know if the ventricles got smaller when they hit their head and got the concussion.The patient was still feeling pressure and was going to see their neurosurgeon the following week.

Manufacturer Narrative

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

Event Description

Additional information received reported the patient recently had a cat scan and was told that their ventricles were very small, almost non existent.The patient went to their neurosurgeon, and they adjusted their valve from 1.5 to 2.0, but the patient still had been having symptoms like pressure and tiredness.The device was adjusted on (b)(4) 2018 and the patient was told to call the office by (b)(6) 2018 if they had symptoms still.When they called the office on (b)(6) 2018 and spoke to the nurse, they said that in order to see a difference they needed to wait at least a week.It was indicated that the patient didn't have headaches, just pressure behind their eyes and nasal cavity area.Additional follow up revealed that the patient was doing well after their setting was changed from 1.5 to 2.0.

Manufacturer Narrative

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

• 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: 7736866
• MDR Text Key: 115778913
• Report Number: 2021898-2018-00380
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 08/08/2018
• 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 Age: 38 YR
• Patient Weight: 66