Model Number SC-1160 |
Device Problem
Inappropriate/Inadequate Shock/Stimulation (1574)
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Patient Problem
Device Overstimulation of Tissue (1991)
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Event Date 09/28/2021 |
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.Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: m365sc2218500, model: sc-2218-50, serial: (b)(4), batch/lot: 7072332/ 7073714.
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Event Description
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It was reported that the patients ipg was causing shock.No device malfunction was suspected.The patient underwent an explant procedure and was doing well postoperatively.
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Manufacturer Narrative
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Sc-1160 sn: (b)(4).The returned ipg was analyzed, passed all tests performed, and exhibited normal device characteristics.Sc-2218-50 sn: (b)(4).The returned lead was analyzed and visual inspection revealed that the lead was cleanly cut approximately 23.5 cm from the proximal end of the lead and the distal portions of the lead was not returned.The clean-cut damage is a result of a typical explant procedure and it is not considered a failure.No other anomalies were identified on the returned portion of the lead.With all the available information, boston scientific concludes: the reported event was not confirmed.
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Event Description
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It was reported that the patients ipg was causing shock.No device malfunction was suspected.The patient underwent an explant procedure and was doing well postoperatively.
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Search Alerts/Recalls
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