Model Number NEU_INS_STIMULATOR |
Device Problems
Failure to Deliver Energy (1211); Low Battery (2584); Battery Problem (2885)
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Patient Problem
Therapeutic Effects, Unexpected (2099)
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Event Type
Injury
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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 healthcare provider (hcp) via a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported the patient was at eri and stimulation was off.It was reported the patient was bi-laterally implanted and one side was 2.26v and the other side was 2.5v and stimulation turned off.The reason for the ins turning off was unknown and the caller could not troubleshoot due to lack of access to the product.No symptoms or complications were reported or 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 received from the health care professional (hcp) via the manufacturer representative (rep).It was reported the patient was having the battery replaced and the issue was resolved at the time of the report.
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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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