MEDTRONIC NEUROMODULATION VERIFY; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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Model Number 3531 |
Device Problems
Migration or Expulsion of Device (1395); Unintended Movement (3026)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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 a trial patient who was using an external neurostimulator (ens) for urgency frequency and fecal incontinence.It was noted that the patient¿s trial started on (b)(6) 2018.It was reported that the patient¿s wire came out and it was recommended that they follow up with their healthcare provider for further assistance.There were no patient complications reported as a result of this event.
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Manufacturer Narrative
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Product id: 3057, lot# unknown, product type: screening device.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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Search Alerts/Recalls
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