Model Number SC-1200 |
Device Problems
Unexpected Therapeutic Results (1631); Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Burning Sensation (2146); Inadequate Pain Relief (2388)
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Event Date 09/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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Exact date unknown, event occurred september 2020 the date the manufacturer became aware of the event.
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Event Description
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It was reported that the patient was experincing inadequate stimulation and burning sensation.It was also noted that the patients device was non functional.The patient underwent an explant procedure and was doing well postoperatively.
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Event Description
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It was reported that the patient was experincing inadequate stimulation and burning sensation.It was also noted that the patients device was non functional.The patient underwent an explant procedure and was doing well postoperatively.
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Manufacturer Narrative
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Sc-1200 sn: (b)(6).The returned ipg was analyzed, passed all tests performed, and exhibited normal device characteristics.
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Search Alerts/Recalls
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