Model Number SC-1160 |
Device Problem
Unexpected Therapeutic Results (1631)
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Patient Problem
Inadequate Pain Relief (2388)
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Event Date 11/28/2021 |
Event Type
Injury
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Manufacturer Narrative
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Event date: exact date unknown, event occurred a few months ago from the date the manufacturer was made aware.
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Event Description
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It was reported that the patient experienced inadequate stimulation.The patient underwent an ipg replacement procedure and was doing well postoperatively.The explanted ipg will not be returned per hospital policy.
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Manufacturer Narrative
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Sc-1160 sn: (b)(6) the returned ipg was analyzed and was fully charged in one cycle, and it did not reveal any anomalies during the visual and functional examination.With all the available information, boston scientific concludes that the reported event was not confirmed.
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Event Description
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It was reported that the patient experienced inadequate stimulation.The patient underwent an ipg replacement procedure and was doing well postoperatively.The explanted ipg will not be returned per hospital policy.
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Search Alerts/Recalls
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