Model Number SC-2316-50E |
Device Problems
Fracture (1260); Device Dislodged or Dislocated (2923)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/19/2020 |
Event Type
malfunction
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Event Description
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It was reported that the patient's lead was fractured during trial procedure.The physician removed the lead and three contacts were sheered off and left inside the patients body.The patient was doing well and continued the trial with full awareness of what happened during the procedure.The explanted trial lead will be returned.
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Manufacturer Narrative
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Sc-2316-50e sn:(b)(6).The returned trial lead was analyzed and it was fractured during trial procedure.The physician removed the lead and three contacts were sheared off and left inside the patients body.The patient was doing well and continued the trial with full awareness of what happened during the procedure.The explanted trial lead will be returned.With all the available information, boston scientific concludes that the allegation of lead body damage was confirmed.Visual inspection revealed that the distal array was fractured between electrode # 3 and 4.Electrodes # 1 to 3 were completely separated from the distal array and the 3 electrodes were not returned.The cables are exposed at the damaged portion of the lead.This kind of anomaly is consistent with the damages done to a lead when the orientation of the insertion needles bevel is facing down, or the angle of the insertion needle is greater than 45 degrees.The probable cause selected is unintended use error caused or contributed to event.
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Event Description
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It was reported that the patients lead was fractured during trial procedure.The physician removed the lead and three contacts were sheered off and left inside the patients body.The patient was doing well and continued the trial with full awareness of what happened during the procedure.The explanted trial lead will be returned.Additional information was received that the patient had a successful lead fragment removal and new spinal cord stimulator was implanted.The patient was doing well postoperatively.
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Search Alerts/Recalls
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