Model Number 97714 |
Device Problems
High impedance (1291); Unintended Collision (1429); Unable to Obtain Readings (1516)
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Patient Problems
Therapeutic Effects, Unexpected (2099); No Known Impact Or Consequence To Patient (2692)
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Event Date 01/01/2016 |
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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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 an implantable neurostimulator (ins) for the treatment of non-malignant pain.It was reported that the patient had a fall in 2016 and gradually lost stimulation.The caller had a hip replacement due to the fall.The patient has high impedances as follows: at.7v lead 0-7 shows >10k, at 3v contact 1 and 3 show >40k and the rest showed xxx.The rep performed a short pmr and the impedances were retested.The xxx was gone but all showed > 40k.The caller dropped their reference and reference 1: only 0-7 shows >40k ohms, contact 2-6: ranging from 27k-36k ohms, 8-15: ranging 800-1400 ohms reference 2: contact 8-15 shows 23k-30k ohms.The caller was redirected to the healthcare provider (hcp) and an x-ray was suggested.No further complications were reported or anticipated.No symptoms 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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Event Description
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Additional information received from the manufacturer representative reported that they advised the patient to contact their surgeon¿s office to have an x-ray and discuss options.The cause of the high impedances was not determined and were not resolved.
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Manufacturer Narrative
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Should have been both adverse event and product problem.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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