Model Number 37714 |
Device Problems
Failure to Interrogate (1332); Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Device Displays Incorrect Message (2591); Battery Problem (2885); Charging Problem (2892); Communication or Transmission Problem (2896); Insufficient Information (3190)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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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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Event Description
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(b)(6).Information was received from a patient regarding their neurostimulator (ins) that was implanted for non-malignant pain and failed back surgery syndrome.Caller reported poor communication.Patient thinks her implant battery is dead because it won't charge.Patient had been having an issue where the implant battery would only charge a half then would only charge a quarter and then it wouldn't charge at all and she finally gave up and implant battery died.This occurred about 2-3 months ago; an exact date was not provided.The last time patient was able to successfully charge was over a month, probably 2-3 months ago.During the call, when patient tried to charge ins she was seeing the reposition antenna screen.Patient was unable to communicate with the external devices and unable to connect with the patient programmer.Patient was redirected to their hcp to address possible overdischarge.Later, patient called back and stated that they called the doctor's office and they said they would be inviting a rep to her upcoming appointment.No symptoms were reported and 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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Event Description
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Additional information was received from the patient.The patient reported that her stimulator (ins) was no longer working as it should.The patient reported that she had an appointment set up.The patient reported that it was pretty much determined that the battery was at end of life, as it was implanted when it was new.The battery had died and needed to be changed.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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