Model Number SC-2218-50 |
Device Problems
Bent (1059); Break (1069); Fracture (1260); High impedance (1291); Kinked (1339); Component Missing (2306)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 08/09/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Additional suspect medical device component involved in the event: model#: sc-2218-50, serial #: (b)(4), description: linear st lead, 50cm.
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Event Description
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A report was received that the patient was experiencing intermittent stimulation.It was noted that the contacts had high impedances.The patient underwent leads replacement procedure.The patient was doing well postoperatively.
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Manufacturer Narrative
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Sc-2218-50 (sn (b)(4)): device evaluation indicated that the complaint of multiple high impedances was confirmed.Visual inspection found lead body was bent/kinked/damaged at the clik anchor site, 1 cm from the set screw mark.The fracture location is 23 cm from the distal end.Cables were not exposed at the clik anchor fracture site.X-ray inspection confirmed all cables were fractured at the bent/kinked section of the lead.The fractured cables resulted in the reported high impedances.Sc-2218-50 (sn (b)(4)): device evaluation indicated that the complaint of multiple high impedances was confirmed.Visual inspection found lead body was bent/kinked/damaged at the clik anchor site, 1 cm from the set screw mark.The fracture location is 19 cm from the distal end.Cables were not exposed at the clik anchor fracture site.X-ray inspection confirmed 6 cables were fractured (electrodes 1, 2, 4, 6-8) at the bent/kinked section of the lead.The fractured cables resulted in the reported high impedances.Sc-4316 (ln 16942458): device evaluation indicated that the clik anchor has a torn eyelet with missing silicone material.
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Event Description
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A report was received that the patient was experiencing intermittent stimulation.It was noted that the contacts had high impedances.The patient underwent leads replacement procedure.The patient was doing well postoperatively.
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Search Alerts/Recalls
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