Model Number 97714 |
Device Problems
Failure to Deliver Energy (1211); Failure to Interrogate (1332); Charging Problem (2892); Communication or Transmission Problem (2896)
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Patient Problem
Therapeutic Effects, Unexpected (2099)
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Event Date 01/01/2016 |
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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A consumer implanted for spinal pain reported via the manufacturer¿s representative (rep) that after (b)(6) of 2016 they had trouble getting coupling, charging, and feeling stimulation.Currently the patient programmer (pp) and recharger were blank and wouldn¿t connect.It was unknown what factors could have led or contributed to this.An appointment was scheduled for (b)(6) for further troubleshooting/interventions, but the issue wasn¿t currently resolved.
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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 was received from a manufacturing representative (rep) reporting that the patient had cancelled their appointment scheduled for today (b)(6).No further information at this time but followup is expected.
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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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