Model Number CI522 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Burning Sensation (2146)
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Event Date 08/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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This report is submitted on february 5, 2021.
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Event Description
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Per the clinic, the patient experienced burning sensations at the magnet site following a magnet dislodgement during an mri scan in (b)(6) 2020.Clinical management of the patient is ongoing.The implanted device remains.
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Manufacturer Narrative
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It was reported that the patient underwent revision surgery to replace the internal magnet (b)(6) 2021.This report is submitted on 20 may 2021.
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Search Alerts/Recalls
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