Model Number SC-8216-70 |
Device Problems
High impedance (1291); Device Dislodged or Dislocated (2923)
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Patient Problems
Undesired Nerve Stimulation (1980); Inadequate Pain Relief (2388)
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Event Date 03/25/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Exact date unknown, event occurred a day prior from the date manufacturer became aware of the event.
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Event Description
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It was reported that the patient was experiencing inadequate stimulation as well as stimulation on a non target area due to high impedances which changes by posture.The patient was reprogrammed, however, unsuccessful.It was noted that the patient had multiple contacts that fell out of the paddle lead and it was confirmed that all the contacts were removed from the patients body.The patient underwent a lead replacement procedure and was doing well post-operatively.
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Event Description
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It was reported that the patient was experiencing inadequate stimulation as well as stimulation on a non target area due to high impedances which changes by posture.The patient was reprogrammed, however, unsuccessful.It was noted that the patient had multiple contacts that fell out of the paddle lead and it was confirmed that all the contacts were removed from the patients body.The patient underwent a lead replacement procedure and was doing well post-operatively.
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Manufacturer Narrative
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Sc-8216-70 sn: (b)(6).The returned lead was analyzed and revealed that the silicone at the paddle lead tails junction was torn and three electrodes were missing from the paddle end of the lead.This type of damage occurs when the lead is exposed to excessive tensile force causing the lead body to stretch and eventually break right at the paddle end.With all the available information, boston scientific concludes the reported event of high impedance was confirmed.The probabale cause is due to unintended use error which caused or contributed to the event.
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Search Alerts/Recalls
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