Model Number 37714 |
Device Problems
Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)
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Patient Problems
Fall (1848); Pain (1994); Swelling (2091); Dizziness (2194); Sleep Dysfunction (2517); Ambulation Difficulties (2544); Electric Shock (2554)
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Event Date 01/01/2018 |
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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Information was received from the patient with an implantable neurostimulator (ins) for non-malignant pain.It was reported that the patient lost their programmer and they were in a lot of pain.Patient said she has had this pain for probably 2 months and had x-ray done by health care professional (hcp) and will speak to the health care professional (hcp) regarding the findings.Patient said this pain is in their right groin going around to their back it's like wrapping around and they think it's been more than two months since it started.It's gotten really worse since then.Within this last month it made walking really difficult and driving too, getting in and out of the car and walking up and down the steps.Patient told to sync patient programmer.Patient programmer showed stim off.Patient said she fell backwards and became dizzy because of the stimulation strength of their stimulator was too high and does not remember when this was but told the health care professional (hcp) about it sometime this year (2018) and the patient thinks the stronger increase in the stimulation could have been the reason they fell backwards.Patient said that she had been looking for their patient programmer and they hurt their knee while looking for the controller under the bed.Patient said they saw the health care professional (hcp) and manufacturing representative (rep).Patient said that she turned stimulation off last night because it was too high and it felt like they were getting electrocuted so they turned it off.Patient was offered some assistance to turn stimulation back on with her implantable neuro stimulator recharger but patient said she needs to wait for the patient programmer to come in because "it needs to be adjusted first, patient cannot just turn it on with the recharger because patient thinks it is at 5 right now but they think it needs to be adjusted before it was turned on".Patient was encouraged to follow up with health care professional (hcp).
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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 consumer reporting that they had swollen ankles and was in pain.No further complications were reported as a result of this event.
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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 consumer reporting that they were in extreme pain and without their programmer.Patient was also unstable with walking and could not sleep at night due to the pain level being at ten.No further complications were reported as a result of this event.
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Search Alerts/Recalls
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