Model Number 97714 |
Device Problems
Failure to Deliver Energy (1211); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896)
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Patient Problem
Therapeutic Effects, Unexpected (2099)
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Event Date 05/17/2017 |
Event Type
malfunction
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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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It was reported that the patient (pt) was experiencing difficulty recharging the implanted neurostimulator (ins) and ins recharger (insr) antenna locate (al) was not working.Ins coupling bars were at zero most of the time and when pt checked ins battery level it was empty and turned off.The pt stated that they normally feel stimulation when it is working, but does not currently feel stimulation.No additional symptoms or complications were reported.
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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 received from the patient reported that the replacement of the recharger resolved the recharging difficulty and the loss of stimulation.
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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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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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