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

Model Number UNKNOWN-S

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Headache (1880); Ventricle, Abnormality Of (2078); Blurred Vision (2137); Ambulation Difficulties (2544)

Event Date 01/01/2009

Event Type  Injury  

Manufacturer Narrative

This event was reported on an online forum and provided to the manufacturer by a separate patient.No further information is available.The country the event occurred in is unknown.Event and implant dates are approximations.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported the patient had been implanted since 2009 and had been experiencing headaches.Reportedly, each time the patient would get a ct scan, it was found that their ventricles were enlarged.It was stated that no adjustments or checks were made.In addition to headaches, the patient¿s balance was off, and they had blurred vision.The patient had ¿just about 20 or so¿ surgeries on their head; in ¿2001, 15 times¿ and in 2009 ¿had to revise it approximately 5 times.¿.

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: 7683757
• MDR Text Key: 113867599
• Report Number: 2021898-2018-00344
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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: 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 Outcome(s): Hospitalization; Required Intervention