Model Number SC-2218-50 |
Device Problems
Bent (1059); Break (1069); Fracture (1260); High impedance (1291); Kinked (1339)
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Patient Problems
Pain (1994); No Known Impact Or Consequence To Patient (2692)
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Event Date 05/02/2018 |
Event Type
malfunction
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Event Description
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A report was received that the patients lead had high impedances.The patient underwent a lead replacement procedure.The patient was doing well postoperatively.
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Manufacturer Narrative
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Additional information was received that the patient was experiencing pain with stimulation use.It was also noted that the bsn representative believed that the lead may be fractured.Sc-2218-50 (b)(4) device evaluation indicated that the complaint has been confirmed.Visual (microscope) and x-ray inspection of the lead revealed that multiple cables were completely broken at the bent/kinked location of the lead.The bent/kinked location is 1 cm from the set screw mark of the clik anchor.There are no exposed cables at the clik site fracture locations.The broken cables resulted in the reported complaint of high impedance.
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Event Description
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A report was received that the patients lead had high impedances.The patient underwent a lead replacement procedure.The patient was doing well postoperatively.
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Search Alerts/Recalls
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