Model Number CI512 |
Device Problems
Use of Device Problem (1670); Device Dislodged or Dislocated (2923)
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Patient Problem
Pain (1994)
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Event Date 11/16/2020 |
Event Type
Injury
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Manufacturer Narrative
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This report is submitted on december 22, 2020.
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Event Description
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Per the clinic, the patient experienced pain during an mri which was completed without the prescribed head wrap.Initially the magnet was pushed back into place but later dislodged again.The magnet is to be replaced on (b)(6) 2020.
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Manufacturer Narrative
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It was reported that the patient underwent revision surgery to reposition the internal magnet on (b)(6) 2021.This report is submitted on 29 january 2021.
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Search Alerts/Recalls
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