Model Number SC-2316-50 |
Device Problems
Bent (1059); Fracture (1260); High impedance (1291); Kinked (1339); Device Or Device Fragments Location Unknown (2590)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/06/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Additional suspect medical device components involved in the event: model: sc-2316-50, serial: (b)(4), description: infinion 1x16 perc lead kit-50 cm; model: sc-3400-30, serial: (b)(4) and 667493 description: infinion splitter 2x8 kit (30 cm).
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Event Description
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A report was received that high impedances were observed on the patients two leads.Per the physician assessment, the cause of the high impedances was a separation at the connection sites of the lead and lead splitters.The physician indicated that the cause of the separation was tension applied at the upper part of the lead splitter during an unrelated procedure.The patient underwent a revision procedure wherein the two leads and two lead splitters were replaced.The patient is doing well post-operatively.
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Manufacturer Narrative
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Additional suspect medical device component involved in the event: model: sc-4316 lot: 19292862 description: next generation anchor kit-sterile sc-3400-30 sn (b)(4) the returned splitters were analyzed and no anomalies were found.Sc-2316-50 sn (b)(4) device analysis of lead revealed that the 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 that cables were fractured at the bent/kinked section of the lead.Additionally, the lead was cleanly cut at 23 cm from tip of distal end.The fractured cables resulted in the reported high impedances.Sc-2316-50 sn (b)(4) device analysis of lead revealed that the lead was cleanly cut at 26 cm from tip of distal end.Damage to the device is similar to that of the typical explant damage and was not considered a failure.X-ray inspections found no cable breakage.Sc-4316: the clik anchor has a torn eyelet with missing silicone material.Additional information was received confirming that no silicone material was left in the patient body.
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Event Description
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A report was received that high impedances were observed on the patients two leads.Per the physician assessment, the cause of the high impedances was a separation at the connection sites of the lead and lead splitters.The physician indicated that the cause of the separation was tension applied at the upper part of the lead splitter during an unrelated procedure.The patient underwent a revision procedure wherein the two leads and two lead splitters were replaced.The patient is doing well post-operatively.
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Search Alerts/Recalls
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