MEDTRONIC NEUROMODULATION VERIFY ENHANCED; STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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Model Number 353101 |
Device Problems
Loose or Intermittent Connection (1371); Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896); Insufficient Information (3190)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/16/2018 |
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 a trial patient who was using an external neurostimulator (ens) for urge incontinence and urgency frequency.It was reported that the patient was charging their programmer the night before and when they went to use it the day of the report, they noticed a message that their programmer lost connection to the ens.The patient attempted to troubleshoot the error by tapping ¿retry¿ to reconnect the programmer, but the issue continued.The patient was advised to contact their healthcare provider to re-establish connection to the ens.It was noted that the trial began on (b)(6) 2018.On a second call, the patient reported that their device was not working earlier, but after taping the loose wire back it was now working.No patient symptoms were reported.No further complications were reported.
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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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Search Alerts/Recalls
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