Model Number 37601 |
Device Problems
Display or Visual Feedback Problem (1184); Device Displays Incorrect Message (2591); Therapeutic or Diagnostic Output Failure (3023)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
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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 healthcare provider (hcp) via a manufacturer representative (rep) regarding a patient with an implanted neurostimulator (ins) for parkinsons dual and movement disorders.The rep reported that the patient had encountered an out of regulation (oor) message on their patient programmer.No patient symptoms were reported.Additional information received from a manufacturer representative (rep) on (b)(6) 2018.The rep reported that the patient was currently in cv mode, but the parameters were unknown.The rep reported that the patient was seeing an oor message on the patient programmer.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Due to imdrf harmonization, any previously submitted device codes no longer apply to this event.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 received from the manufacturer representative reported that the cause of the reported event was not determined.However, the physician was able to clear the oor with the clinician programmer by reducing the voltage.The patient was now receiving therapy.No further patient complications have been reported as a result of this event.
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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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