Model Number 3116 |
Device Problems
Inappropriate/Inadequate Shock/Stimulation (1574); Electro-Static Discharge (2149)
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Patient Problems
Complaint, Ill-Defined (2331); Electric Shock (2554)
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Event Date 06/04/2016 |
Event Type
Injury
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Event Description
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The consumer reported that the patient drove into a lightning storm on 2016-06-04 and this might have affected their stimulator.The patient was experiencing shocking and a lot of gastrointestinal symptoms with it.The patient's primary health care provider (hcp) requested a clinician programmer and the patient wanted to know if it had been sent to the location.The hcp initially wanted the remote for a normal appointment, but now wanted it sooner because the patient was being shocked.They used to send the remote to the hcp all the time.The indication for use for this patient was gastrointestinal/pelvic floor.
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Event Description
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Additional information received from the patient reported adjustments failed to help with the shocking.The patient received a new device and had an omentum flap surgery with it on (b)(6) 2016.Following the procedure, the patient did not have shocking and the gastrointestinal symptoms had resolved.The patient was at a much higher setting and they did not have to take any daily medications for gastrointestinal symptoms, pain, or dysautonomia.
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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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