Model Number 97714 |
Device Problems
Energy Output Problem (1431); Appropriate Term/Code Not Available (3191)
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Patient Problems
Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)
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Event Date 06/01/2018 |
Event Type
malfunction
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from the patient on 2018-jul-20.It was reported that the patient was still feeling pain after she changed to group d on (b)(6) 2018; they were requesting to change to a different group to find relief.The patient was able to program to group b, but it was not giving her enough back coverage but when she programmed to group a, adaptive stimulation was activated.The stimulation was increased, and the patient stated that she was feeling stim in the target area, but it will take time to know if it will alleviate her pain.In the end, the patient was redirected to follow-up with their healthcare professional (hcp) regarding the pain levels and programming.There were no further complications reported or anticipated.
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Manufacturer Narrative
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Occupation: non-healthcare professional.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a consumer regarding a patient who was implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that in (b)(6) 2018, after a manufacturer representative (rep) had helped the patient move from program 1 to program b, the patient started having lower back pain.Troubleshooting took place on the call.The patient was currently on program b and was assisted with moving to program c.At 5.6 volts, the patient commented they needed the stimulation to be stronger so it was raised to 7.0 volts.The patient was going to try that setting for a little bit of time, and said they would call back if it doesn't help.There was no mention of any trauma, falls, emi, etc during the call.No further complications were reported or anticipated.Additional information was received from the patient.It was reported that the patient is on group c and it was helping her until (b)(6) 2018.The patient was feeling more pain flare up in her lower back and left leg.The patient was walked through how to change to group d and then felt stimulation in the lower back and left thigh where she needs it.The patient stated it may take a little while for the therapy to bring down her pain.No further complications were reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from the patient.It was reported that the a change in device programming led to the device suddenly not helping.No further complications were reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information was received from the patient.It was reported that the patient was still having the same issue with her therapy (pain control).The patient wanted assistance changing the program to a different program.The patient has not followed up with their hcp because they were told to call the manufacturer.The patient was assisted to change from program h to program f.The patient was told to follow up with the hcp if the program change did not help.It was also mentioned that a manufacturer representative could be there to make sure that the programming works for her.No further complications were reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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