Model Number 97714 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Low Battery (2584); Battery Problem (2885); Charging Problem (2892)
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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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Information was received from a consumer via manufacturer representative regarding a patient who was implanted with a neurostimulator.It was reported that the device does not hold a charge like it used to.They had not used the device in several months.The implantable neurostimulator (ins) was overdischarged and it was stated that the ins had been overdischarged at least once before.The clinician programmer tried to interrogate the ins but this was unsuccessful because the ins was overdischarged.The patient was educated on a trickle charge and they would be follow-up with on (b)(6) 2018.The issue was not yet resolved.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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Event Description
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Additional information was received on 2018-jul-17 noting that the patient had trouble recharging at home and the device has to be constantly charged.It was too time consuming and hard to keep up with.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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Event Description
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Additional information received from a manufacturer representative (rep) reporting that the cause of the ins not holding a charge was due to the patient not charging it.It was indicated that the ins was able to be brought out of overdischarge.It was indicated that the provided information had been confirmed with the physician.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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