INNERVISION SNAP SHUNT VENTRICULAR CATHETER, STANDARD, 6CM
Received Jul 19, 2017 · Event occurred Jun 2, 2017
Report 2021898-2017-00387 · MDR key 6725983
Device
Generic name
Catheter, Ventricular
Manufacturer
Medtronic NeurosurgeryCatalog number
27065 C
Lot number
E18646
Product problems
- Device Operates Differently Than Expected
- Device Operates Differently Than Expected
Patient
19 YR
- Therapeutic Response, Decreased
- Therapeutic Response, Decreased
Narrative
Additional Manufacturer Narrative
THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL CATHETERS ARE 100% INSPECTED AT THE TIME OF MANUFACTURE. PLEASE REFER TO THE MANUFACTURER REPORT 2021898-2017-00385 FOR PREVIOUS VALVE ISSUES. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem
IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT ON (B)(6) 2017, THE PHYSICIAN'S NOTES SHOWED THEY LEFT THE NEW VALVE AT THE PRIOR SETTING, BUT THE PATIENT WAS NOTED TO HAVE HYDROCEPHALUS. REPORTEDLY, THE PATIENT WENT TO SURGERY ON (B)(6) 2017 AND HAD A VENTRICULOPERITONEAL (VP) SHUNT REVISION. THE PHYSICIAN'S OPERATIVE NOTE STATED THEY DECIDED TO REPLACE THE VALVE AND CHANGE THE SETTING AS WELL AS REPLACE THE PROXIMAL CATHETER WITH ANOTHER CATHETER.