Model Number 97715 |
Device Problems
Device Operates Differently Than Expected (2913); Improper Device Output (2953)
|
Patient Problems
Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331)
|
Event Date 05/28/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Information was received from a consumer regarding a patient who was implanted with a neurostimulator (ins) for non-malignant pain.It was reported that the patient was getting ¿blasted¿ and they could not adjust stimulation.They were unable to turn off the device.The patient stated that the controller was stuck on the screen saying, ¿please wait¿ with the circle spinning, but they were getting blasted.The patient stated that the controller was out of control.Technical services (ts) had the patient reseat the battery pack which resulted in the normal therapy screen.The patient was able to decrease stimulation and turn it off.They noted this was the first time this had happened.No further complications were reported.Follow up was conducted.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Information was received from a patient with an implantable neurostimulator (ins) for 2018-sep-14.The patient indicated hat the err or code on the controller after it was unlocked was a circle of dots and a ¿please wait¿.No further complications were reported/are anticipated.
|
|
Search Alerts/Recalls
|