Model Number 97715 |
Device Problems
Failure to Deliver Energy (1211); Energy Output Problem (1431); Appropriate Term/Code Not Available (3191); Unexpected Shutdown (4019)
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Patient Problems
Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Effects, Unexpected (2099); No Known Impact Or Consequence To Patient (2692)
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Event Date 07/25/2018 |
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 a manufacturing representative (rep) regarding a patient with an implantable neuro stimulator (ins) for spinal pain.It was reported that controller malfunction.While rep was educating the patient during the post op visit, the controller turned the device off while they were switching groups.Rep tuned the device back on.The issue was resolved at the time of this report.No surgical intervention occurred or planned.No patient symptoms or complications were reported in 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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Manufacturer Narrative
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Concomitant medical products: product id: 97745 , serial# (b)(4), product type: programmer, patient.If information is provided in the future, a supplemental report will be issued.
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Event Description
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On 2018-aug-30, information was received from a manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins) for spinal pain.It was reported that the controller/recharging was stopping and the screen was turning off.It was reviewed the ins will charge faster if the controller screen is off.It was unknown if charging was still active (blinking light) but the patient did indicate she had to start the recharge process.This has happened a few times and not on every occasion.The rep was going to ask the patient if they physically needed to restart the recharging or if turning the controller on continued recharging.The issue started within the last month.No symptoms or further complications were reported.On (b)(6)2018, additional information was received from a manufacturer representative (rep) clarifying the report of whether the recharging was still active when the controller screen was turning off.It was reported that the patient stated that they had to check again, but they were pretty sure they had to "reboot" the charging when they noticed the screen was off.They stated that they would start paying attention to the blinking green light as well.It was reported that the cause of the controller screen turning off/recharging stopping was not determined and it had happened one more time since the rep met with the patient two weeks ago.It was indicated that the patient was keeping a journal of it.Actions taken to resolve the issue was the patient was keeping a journal of it.It was reported that the issue had not been resolved but that it had also only happened once in the past two weeks.It was indicated that the provided information had been confirmed with the physician.Additional information was received from the rep on 2018-09-1 2, stating that they had submitted a report for the patient in (b)(6) as their controller had turned the device off while they were educating them on how to use it, stating they were nowhere near the option to turn the device off.They stated that they just realized there as a pattern here as they were following up with the patient last night.No further complications were reported/anticipated.On (b)(6) 2018, additional information was received from a manufacturer representative (rep) reporting that when they followed up with the patient last night in regards to their previously reported issues they also mentioned that their device sometimes feels like it was on even though they had turned it off.They mentioned that this started about 3 to 4 weeks ago and when this happened they would turn on the controller to check but the device was still off, however they felt stimulation.It was stated that they talked about how it could be residual effect potentially, but they said it was just as strong as when the device was truly on.It was unknown if any factors contributed to the controller/device issues.It was reported that the patient has and would continue to document each time they had issues with the device and controller.It was reported that the issue was resolved.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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Information was received from a manufacturing representative (rep) regarding a patient with an implantable neuro stimulator (ins) for spinal pain.It was reported that controller malfunction.While rep was educating the patient during the post op visit, the controller turned the device off while they were switching groups.Rep tuned the device back on.The issue was resolved at the time of this report.No surgical intervention occurred or planned.No patient symptoms or complications were reported in this event.
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Search Alerts/Recalls
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