MEDTRONIC PUERTO RICO OPERATIONS CO. INTERSTIM II; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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Model Number 3058 |
Device Problems
Failure to Deliver Energy (1211); Unintended Collision (1429); Device Operates Differently Than Expected (2913)
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Patient Problems
Incontinence (1928); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)
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Event Date 02/01/2018 |
Event Type
malfunction
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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 their implantable neurostimulator (ins) for urinary dysfunction/sacral nerve stimulation and gastrointestinal/pelvic floor.It was reported that patient's therapy had been working on program 4 to provide at least 50% symptom control, but that programs 1, 2, and 3 never worked to control their symptoms.Patient stated they had a sudden return of symptoms and was going through 5-6 pads per day.This occurred 4 to 5 months ago but they had been dealing with other medical issues, not related to device, and had not addressed the lack of symptom control.Patient mentioned symptoms had been worsening lately and were worse than baseline.Patient tried turning stimulation up from their normal setting of 3.5 or 4, to 8 but was not feeling stimulation.It was noted patient had fallen 3 or 4 times in the last few months and fell on their butt at least once.No further complications were reported.
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Search Alerts/Recalls
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