Model Number SC-1132 |
Device Problems
Positioning Problem (3009); Migration (4003)
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Patient Problem
No Code Available (3191)
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Event Date 04/15/2020 |
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 patient's ipg had migrated.It was also noted that the charger will not stop beeping when placed over implant.The patient underwent an ipg replacement procedure and was doing well postoperatively.The explanted ipg was not returned.
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Manufacturer Narrative
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Sc-1132 (sn (b)(6)).The returned ipg was analyzed, passed the functional test, and an electrical test revealed normal device characteristics.The reported event was not confirmed as reported observation with testing of the product return.Hence, the probable cause selected for this complaint is no problem detected.
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Event Description
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It was reported that patients ipg had migrated.It was also noted that the charger will not stop beeping when placed over implant.The patient underwent an ipg replacement procedure and was doing well postoperatively.The explanted ipg was not returned.
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Search Alerts/Recalls
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