Model Number 3116 |
Device Problems
Disconnection (1171); High impedance (1291); Insufficient Information (3190)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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Healthcare professional.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 professional (hcp) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that, upon interrogation, there was an issue discovered with the system.The leads had become disconnected and there were high impedances.A manufacturer representative (rep) suggested an endoscope and x-ray, which were performed on 2018-07-27 and the patient was waiting to schedule an appointment to have a replacement.No symptoms or further 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 was received from a hcp.It was reported that the cause of the disconnection was unknown.
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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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