Model Number 97714 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
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Patient Problem
Confusion/ Disorientation (2553)
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Event Date 11/05/2015 |
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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Information was received from a healthcare provider (hcp) about a patient with an implantable neurostimulator (ins) for spinal pain.It was reported that the patient was confused and could not answer questions, so the healthcare provider was working with the patient¿s wife.The wife reported that the device was non-functioning due to a battery malfunction.It was reported that it was unclear what this meant.It was not known when this event occurred.
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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 manufacturer representative.It was reported that the ins was overdischarged.It was reported that the ins recharger displayed a power on reset (por) message after physician mode reset (pmr) was performed.The manufacturer representative did not clear the por and advised the patient charge the ins in the office, then to charge the ins at home.It was reported that the patient was not able to charge the ins since 2015.No complications were reported.
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Event Description
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Additional information received from the manufacturing representative indicating that the patient¿s overdischarge and por has been resolved.They did not know the patient¿s weight at the time of the event.No further complications were reported.
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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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