Patient age not available from the site.Patient weight not available from the site.The shunt was returned to the manufacture for evaluation.The complaint reports that after the shunt was implanted, an infection occurred.Due to the use of the same sterilization equipment and nature of pressurized testing for valves and catheters, the device will not be decontaminated or tested in the pe lab to accommodate laboratory personnel safety.The device has been discarded.If information is provided in the future, a supplemental report will be issued.
|
Medtronic received information regarding a shunt and catheter being used in a procedure.It was reported that after the shunt and catheter were implanted, there was a postoperative infection that occurred.The drainage was not smooth and multiple pressure adjustments occurred.The site stated that after the shunt and catheter were implanted, the patient developed an infection, the shunt was not smooth, and the pressure was adjusted several times in the middle, but it was ineffective.Additional information was received stating that medication was provided to the patient to help with the infection.Both the shunt and the catheter were replaced.The patient has now recovered from the infection.
|