Model Number 97702 |
Device Problems
Energy Output Problem (1431); Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885); Device Operates Differently Than Expected (2913)
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Patient Problems
Pain (1994); Discomfort (2330)
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Event Date 05/28/2018 |
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¿s friend/family member regarding the patient with an implantable neurostimulator (ins) for non-malignant pain.It was reported that the patient¿s device was at eos (end of service).It was reviewed that the device was off/disabled and no longer providing therapy.It was reviewed that the patient should contact their managing healthcare provider (hcp) to schedule a replacement surgery.It was indicated that the patient initially reported seeing the eri (elective replacement message) on their programmer and during the call they stated it changed to eos ((b)(6) 2018).There was no allegation/dissatisfaction with the ins longevity.It was reported that the patient had been uncomfortable and in a lot of pain.It was reported that their pain and discomfort began on (b)(6) 2018.Their device was at eri on (b)(6) 2018.No further complications were reported/anticipated.
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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 a consumer.It was reported that the ins had gone dead and the patient's pain level was at a 10 because the ins was out.The patient had a consultation for a replacement surgery but the doctor they met with told them the surgery could not be done at a surgery center, but rather would need to be done in a hospital because of the patient's pre-existing conditions including: congestive heart failure, chronic obstructive pulmonary disease (copd), a bladder issue, and of being older in age.It was noted that the caller did not allege that these pre-existing conditions were related to the device/therapy.Therefore, the caller has been having a hard time finding a doctor to perform the replacement surgery.Manufacturer representatives (reps) were contacted for assistance.A rep contacted the caller and provided them with names and numbers of two surgeons in their area.No further complications were reported or anticipated.
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Manufacturer Narrative
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Contains all applicable codes.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 consumer on (b)(6) 2018 reporting that they could tell if the ins was working or not working.The patient had gone to the clinic but the hcp was not able to take care of them at the hospital setting.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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