Model Number CI622 |
Device Problem
Expulsion (2933)
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Patient Problems
Wound Dehiscence (1154); Tissue Breakdown (2681)
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Event Type
Injury
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Event Description
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Per the clinic, the patient experienced an extrusion of the implanted device (date not reported).Additional information has been requested but has not been made available as of the date of this report.
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Event Description
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Per the clinic, the device was explanted (date not confirmed).It is unknown if there are plans to re-implant the patient with a new device.Additional information has been requested but it has not been made available as of the date of this report.
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Event Description
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Per the clinic, the patient also experienced wound dehiscence at the incision site (date not reported).The date of explant is now confirmed to be (b)(6) 2023.
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Search Alerts/Recalls
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