Model Number 97714 |
Device Problems
Failure to Deliver Energy (1211); Labelling, Instructions for Use or Training Problem (1318); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
|
Patient Problem
Therapeutic Effects, Unexpected (2099)
|
Event Date 07/15/2016 |
Event Type
malfunction
|
Event Description
|
A consumer reported the patient was implanted on (b)(6) 2016 and was supposed to feel stimulation in both their arms and neck, but as of (b)(6) 2016 they weren¿t feeling stimulation in their neck.The patient tried increasing stimulation, and could feel it increasing, but not in their neck.The manufacturer¿s representative (rep) was going to call the patient regarding the issue.Relevant medical history includes spinal pain.
|
|
Manufacturer Narrative
|
Concomitant medical products: product id neu_label_acc, product type: accessory.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
|
Additional information received from the patient indicated there was a loss of stimulation.The patient had been programmed by a manufacturer representative (rep) but since then the patient had done something with the programmer and ¿screwed it all up.¿ stimulation was only reaching the left side.Stimulation was strong in the left are up to the neck, but was weaker on the right side and stimulation was supposed to target both arms up to the neck.Therapy did help on the right side when the patient cocked their head to the right and could not feel stimulation when laying down.The patient also saw a poor communication screen when trying to communicate but was able to bypass it.Adjusting stimulation did not resolve the issue.Circumstances that led to the lack of stimulation in the neck included two fusions resulting in nerve damage and medication not working.The patient was having problems programming and understanding the manual for the stimulator.Steps to resolve the lack of stimulation included physical therapy, ¿tens¿ unit, medication and injections.
|
|
Event Description
|
Additional information provided by a manufacturer representative reported that the patient was doing fine.The manufacturer representative stated that they met with the patient in the clinic for reprogramming as well as re-education.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|