MEDTRONIC NEUROSURGERY STRATA II VALVE, REGULAR; SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS
|
Back to Search Results |
|
Catalog Number 42866 |
Device Problem
Inaccurate Flow Rate (1249)
|
Patient Problem
Therapeutic Response, Decreased (2271)
|
Event Date 03/02/2017 |
Event Type
Injury
|
Manufacturer Narrative
|
The returned valve was patent.The valve met the requirements for siphon, reflux, pressure flow, and preimplantation testing.The valve did not meet requirements for leak testing due to a tear in the top of the delta chamber.It is unknown how or when this damage occurred.The ifu cautions that ¿care should be taken in handling the valves as silicone has a low cut and tear resistance.¿ the ifu also cautions that ¿improper use of instruments in the handling or implantation of shunt products may result in the cutting, slitting, crushing or breaking of components.¿ proteinaceous debris was observed within the interior and exterior of the valve.A review of the manufacturing records was not possible as no lot number was provided.All valves are 100% tested 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.
|
|
Event Description
|
It was reported to medtronic neurosurgery that overdrainage occurred with the patient's device even at the performance level 2.5.According to the report, the device was explanted and replaced.Reportedly, there was no injury to the patient.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|
|
|