Model Number 97714 |
Device Problems
Migration or Expulsion of Device (1395); Unable to Obtain Readings (1516); Self-Activation or Keying (1557); Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problems
Pain (1994); Electric Shock (2554)
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Event Date 06/20/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).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 manufacture representative regarding a patient implanted with an implantable neurostimulator (ins) for spinal pain.It was reported that the rep ran an impedance check and saw 'xxx.' the rep re-ran the check and the xxxs cleared up.It was also reported that the patient feels intermittent jolting when they sleep at night, even though they don't move.The intensity was increasing on its own.It was noted that adaptive stimulation was enabled.No further complications were reported.
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Manufacturer Narrative
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Concomitant medical products: product id 977a260, implanted: (b)(6) 2016, product type lead; product id 977a260, implanted: (b)(6) 2016, product type lead.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 reported that the cause of the patient's intermittent jolting was due to their leads migrating up 2 vertebral spaces.The patient is being scheduled for a revision of their leads.No further information was reported.
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Manufacturer Narrative
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Corrected information.If information is provided in the future, a supplemental report will be issued.
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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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Other applicable components are: product id: 977a260, serial# (b)(4), implanted: (b)(6) 2016, product type: lead.Product id: 977a260, serial# (b)(4), implanted: (b)(6) 2016, product type: lead.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 received from the reported that the lead revision was scheduled for (b)(6) 2018.No further complications were reported.
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Search Alerts/Recalls
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