Model Number 37800 |
Device Problems
Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913)
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Patient Problems
Twiddlers Syndrome (2114); No Known Impact Or Consequence To Patient (2692)
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Event Type
Injury
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Manufacturer Narrative
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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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Event Description
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A healthcare provider (hcp) reported that the patient had their whole implantable neurostimulator (ins) system removed and replaced because it was all tangled up.There was no other information available at the time of the report.No further complications are anticipated.
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Manufacturer Narrative
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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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Event Description
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Additional information from the hcp stated that the patient was probably twisting the generator in the pocket.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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Search Alerts/Recalls
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