Model Number 3116 |
Device Problems
Low Battery (2584); Battery Problem (2885); Electromagnetic Compatibility Problem (2927)
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Patient Problem
Therapeutic Response, Decreased (2271)
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Event Date 09/01/2017 |
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 consumer regarding a patient with an implantable neurostimulator (ins) for gastric stimulation.It was reported that the patient had a fibroscan in (b)(6) 2017, then in (b)(6) 2017, the patient found out that the ins was dead.The patient was unsure if the fibroscan was related to the implant dying.The patient had a loss of therapy and had a new implant in (b)(6) 2017.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 received from a consumer (con).It was reported that the patient wasn't sure where the battery was.The patient wasn't sure if the device dying was due to battery life or the fibroscan.
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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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No new information was reported (the patient's weight at the time of the event was provided).
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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 consumer (con).It was reported that the patient wasn¿t sure where the device was; the battery was removed.
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Search Alerts/Recalls
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