Model Number 97714 |
Device Problems
Energy Output To Patient Tissue Incorrect (1209); Migration or Expulsion of Device (1395)
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Patient Problem
Undesired Nerve Stimulation (1980)
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Event Date 01/14/2017 |
Event Type
Injury
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Manufacturer Narrative
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The main component of the system and other applicable components are: product id: neu_unknown_lead, serial# (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2017, product type: lead.
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Event Description
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Information was received from a consumer regarding a patient who was implanted with a neurostimulator (ins) for non-malignant pain.It was reported that the leads moved and the patient started feeling stimulation in the stomach, so it was replaced.No further complications were reported.Follow-up was conducted.
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Manufacturer Narrative
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The phrase "so it was replaced" should be corrected to "so the system was replaced." a good faith effort will be made to obtain the applicable information relevant to the report.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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Search Alerts/Recalls
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