INNERVISION SNAP SHUNT VENTRICULAR CATHETER KIT
Received Aug 17, 2016
Report 2021898-2016-00283 · MDR key 5882403
Device
Generic name
Catheter, Ventricular
Manufacturer
Medtronic NeurosurgeryCatalog number
27298
Lot number
D62266
Product problems
- Appropriate Device Problem Term/Code Not Available
- Appropriate Device Problem Term/Code Not Available
Patient
13 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. 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 THROUGH A LEGAL CLAIM LETTER THAT THE DEVICE HAD FAILED AND THE PATIENT SUFFERED A BRAIN HEMORRHAGE AND PERMANENT AND DEBILITATING INJURIES.
Additional Manufacturer Narrative
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.