Model Number 7427 |
Device Problems
High impedance (1291); Unable to Obtain Readings (1516)
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Patient Problems
Pain (1994); Therapeutic Effects, Unexpected (2099)
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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 manufacturer representative (rep) regarding a patient with an implantable neurostimulator (ins) for other pain indications - other.It was reported that there were high impedances on electrodes 5,6,7.It was noted that there were invalid impedance readings of "???" with electrode pairs 2<(>&<)>3, 3<(>&<)>5, 4<(>&<)>5 and 5<(>&<)>6.The rep did an impedance check and a battery check and the ins voltage was at 2.56.The rep performed reprogramming but was unable to cover one area of pain.It was noted that the issue was not resolved at the time of the report.No further complications were reported/anticipated.
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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 was received from the manufacturer's representative.It was reported that the cause was not determined.Rep reported they attempted to reprogram around the lead.Only covers one of the two areas of pain.Surgeon and patient are deciding if they will have a revision.
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Search Alerts/Recalls
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