Model Number 37603 |
Device Problems
Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)
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Patient Problems
Muscular Rigidity (1968); Complaint, Ill-Defined (2331)
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Event Date 12/07/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Product id: 37603, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator.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 and health care provider (hcp) regarding a patient who was implanted with a neurostimulator (ins) for dystonia and movement disorders.It was reported the patient was struggling with their right arm as of the day prior to this report.The issue started and got better, but it was worse now.It was noted the left ins controls the right side.It was stated a nurse checked the ins batteries and the right ins connected, but there was poor communication with the left ins.The consumer wondered if that meant the ins was dead because the patient has high settings and an health care provider (hcp) stated the inss would be depleting soon.Additional information was received from the nurse.It was reported that the left ins connected fine, but there was poor communication with the right ins.This contradicts the previous report that the left ins had poor communication.The issue was resolved while trying to re-connect with the ins.The ins displayed ¿ok¿.It was noted the patient had poor tone and more stiffness the day prior to this report and the day of this report.It was also noted that it could be due to the cold, but this was not known for certain.No further complications were reported.
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Search Alerts/Recalls
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