Model Number SC-2218-50 |
Device Problems
Bent (1059); Fracture (1260); High impedance (1291); Kinked (1339)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 01/18/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Addiconcomitant medical products: 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 inadequate stimulation.It was noted that multiple contacts were not active.It was unknown why the patient got some contacts out.Database analysis revealed high values on 2 contacts(port a), 3 contacts (port b), and 8 contacts (port d).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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(b)(4) device evaluation indicated that the lead was cleanly cut approximately 25 cm from the distal end.Electrical tests could not be performed due to broken cables.The damage to the lead is consistent with damages done during the explant procedure and it is not considered a failure.(b)(4) device evaluation indicated that the complaint has been confirmed.The 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.(b)(4) device evaluation indicated that the clik anchor has a missing silicone material from one of the torn eyelets.Additional information was received that the physician confirmed that nothing was left in the patient¿s body.The remaining piece of the eyelet was disposed.
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Event Description
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A report was received that the patient was experiencing inadequate stimulation.It was noted that multiple contacts were not active.It was unknown why the patient got some contacts out.Database analysis revealed high values on 2 contacts (port a), 3 contacts (port b), and 8 contacts (port d).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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