Model Number 97715 |
Device Problems
Electromagnetic Compatibility Problem (2927); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Nausea (1970); Dizziness (2194)
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Event Date 04/19/2018 |
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 consumer regarding a patient with an implantable neurostimulator (ins) for spinal pain.It was reported that the patient was having problems with dizziness, light headedness, and nausea and was wondering if they could be related to the device, or if they are related to the non-device related gall bladder surgery that the patient had on (b)(6) 2018.It was reviewed the patient could turn off the device to see if symptoms went away and that the patient should follow up with their healthcare provider (hcp) to determine the cause of the issues.No further complications were reported.
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Manufacturer Narrative
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(b)(4).The gall bladder surgery was prior to implant, so no emi was possible.Review of this mdr and/or additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements stipulated in 21 cfr 803.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Mdr decision corrected to not reportable.No additional supplementals required unless additional information received indicates reportable event.
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Search Alerts/Recalls
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