Model Number 3058 |
Device Problems
Unintended Collision (1429); No Device Output (1435); Unstable (1667); Battery Problem (2885); Output Problem (3005); Unintended Movement (3026); Appropriate Term/Code Not Available (3191)
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Patient Problems
Incontinence (1928); Pain (1994)
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Event Date 05/15/2018 |
Event Type
Injury
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Manufacturer Narrative
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Occupation: non-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 consumer regarding a patient who was implanted with an implantable neuro stimulator (ins) for fecal incontinence and gastrointestinal/ pelvic floor patient reported that they had their ins revised on (b)(6) 2018 because it was flopping around and hurting.Power on reset message when they try to turned their ins on after the revision.Patient has an appointment to see their health care professional no further complications were noted 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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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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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 reported that patient fell on the ground was the cause of the implant flopping around and por (power on reset).The patient took the remote to the doctor 's office and one of the representative reset it for the patient and the por issue was resolved.
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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 the patient.It was reported that they were unable to turn on their device.No further complications were reported or anticipated.
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Search Alerts/Recalls
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