Model Number SC-2317-70 |
Device Problems
Fracture (1260); High impedance (1291); Appropriate Term/Code Not Available (3191); Migration (4003)
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Patient Problem
No Code Available (3191)
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Event Date 02/14/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Additional medical suspect device components involved: reference number: (b)(4), product family: scs-linear leads, upn: (b)(4), model: sc-2317-70, serial: (b)(4), batch: (b)(4).
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Event Description
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A report was received that high impedances were measured on the patient's leads.The high impedances were noted on contacts 2-3 and 10-11.The patient underwent a lead revision procedure where the lead was explanted.The lead was loose from the ipg header.The lead was noted to be very weak and bent about 4cm away from the 1st contact of the bsn splitter.The lead seems to have been broken.
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Event Description
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A report was received that high impedances were measured on the patient's leads.The high impedances were noted on contacts 2-3 and 10-11.The patient underwent a lead revision procedure where the lead was explanted.The lead was loose from the ipg header.The lead was noted to be very weak and bent about 4cm away from the 1st contact of the bsn splitter.The lead seems to have been broken.
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Manufacturer Narrative
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Additional information was received that lead serial number (b)(4) was not explanted from the patient.The complaint high impedances were confirmed.Visual (microscope) and x-ray inspection of the lead revealed that all cables were completely broken at the bent/kinked location of the lead.The bent/kinked location is 2 cm from the set screw mark of the clik x anchor.There are no exposed cables at the clik x anchor site fracture locations.The reported complaints of high impedances were caused by the fractured cables at the clik x anchor site.Additionally, the distal end of lead was cut and not returned.The cut damage to the lead is consistent with damages done during the explant procedure and are not considered a failure.
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Search Alerts/Recalls
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