Model Number SC-8352-70 |
Device Problems
Difficult to Remove (1528); Unexpected Therapeutic Results (1631)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/27/2021 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: approximated based on the date the manufacturer became aware of the event.
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Event Description
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It was reported that the patients old paddle was up too high from where the trial was years ago and was also not getting adequate pain relief.The physician initially planned to replace the whole system but was unable to get the old paddle out, and therefore left the paddle lead and cut the tails off.
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Event Description
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It was reported that the patients old paddle was up too high from where the trial was years ago and was also not getting adequate pain relief.The physician initially planned to replace the whole system but was unable to get the old paddle out, and therefore left the padldle lead and cut the tails off.Additional information was received that the lead was explanted and returned.
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Manufacturer Narrative
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Sc-8352-70 (b)(6).The returned paddle lead was analyzed, and the lead was cleanly cut, and the paddle was not returned.No anomalies were identified on the lead aside from the clean-cut.The damage to the lead is a result of a typical explant procedure, and it is not considered a failure.
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Search Alerts/Recalls
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