Model Number SC-2317-70 |
Device Problems
Bent (1059); High impedance (1291); Kinked (1339)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 08/18/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Additional suspect medical device component involved in the event: model #: sc-2317-70 serial #: (b)(4) description: infinion cx 70 cm lead.
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Event Description
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A report was received that the patient was experiencing inadequate stimulation.It was also noted that patient's leads were corrupted and had high impedances.The patient underwent a revision procedure wherein the leads were replaced.The patient was doing well postoperatively.
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Manufacturer Narrative
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Sc-2317-70 (sn (b)(4)): device evaluation indicated that the complaint of the leads had been confirmed.Visual (microscope) and x-ray inspection of the leads revealed that multiple cables were completely broken at the bent/kinked location of the lead.The bent/kinked location was 1 cm from the set screw mark of the clik anchor.There were 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 patient was experiencing inadequate stimulation.It was also noted that patient's leads were corrupted and had high impedances.The patient underwent a revision procedure wherein the leads were replaced.The patient was doing well postoperatively.
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Search Alerts/Recalls
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