Model Number SC-1110 |
Device Problems
Device Stops Intermittently (1599); Reset Problem (3019)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 06/02/2014 |
Event Type
malfunction
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Event Description
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A report was received that the patient's ipg was turning off by itself numerous times.It was noted that the patient had a non-device related surgery.Ipg database analysis revealed no anomalies.The history counter showed multiple resets have occurred.The ipg appeared to be working as expected.The patient will undergo an ipg replacement procedure.The physician suspected device malfunction.
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Manufacturer Narrative
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Sc-1110 (sn (b)(4)) device evaluation indicated that the complaint was not verified.The reported stimulation anomaly was not observed as the ipg was investigated with known good test leads.The monitored stimulation on an oscilloscope found that the outputs were consistent and amplitude/pulse widths were verified to be correct on all the electrodes.Current leakage tests and residual gas analysis verified no loss of electric current into the surrounding tissue as a result of faulty insulation.The ipg passed all the required tests and revealed no anomalies.The complaint of the device turning off by it couldn't be duplicated.
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Event Description
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A report was received that the patient's ipg was turning off by itself numerous times.It was noted that the patient had a non-device related surgery.Ipg database analysis revealed no anomalies.The history counter showed multiple resets have occurred.The ipg appeared to be working as expected.The patient will undergo an ipg replacement procedure.The physician suspected device malfunction.
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Search Alerts/Recalls
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