Model Number ASKU |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Pain (1994); Swelling/ Edema (4577)
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Event Type
malfunction
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Manufacturer Narrative
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This report is submitted on october 14, 2020.
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Event Description
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It was reported the patient experienced pain and swelling at the magnet site following a magnet dislodgement during an mri (3 tesla).The patient was placed under sedoanalgesia in order to explant the implant magnet (specific date not reported).The internal magnet has not yet been replaced.The implanted device remains.
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Manufacturer Narrative
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This mdr was a duplicate.Any further information will be provided with report number (b)(4).This report is submitted on 12 mar 2021.
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Search Alerts/Recalls
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