Model Number 97715 |
Device Problems
Energy Output Problem (1431); Data Problem (3196)
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Patient Problem
Complaint, Ill-Defined (2331)
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Event Date 12/11/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: product id: 97745, serial#: unknown, product type programmer, patient.Other relevant device(s) are: product id: 97745, serial/lot #: unknown.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 professional (hcp) via a manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins) for the treatment of radiculopathy and spinal pain.It was reported that the patient programmer (pp) kept going back to ¿0¿ or a very low setting.The patient was somewhat unsatisfied with the therapy.The settings were changed according to protocol.The outcome of the event was unknown.
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Manufacturer Narrative
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Product id 97745, serial# unknown.Product type programmer, patient.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 was received from the rep.They stated the event was determined to be related to the adaptive stimulation resetting.There was no further indication that the issue reoccurred.No patient complications were reported as a result of this event.
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Search Alerts/Recalls
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