Model Number OSI200 |
Device Problem
Expulsion (2933)
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Patient Problems
Wound Dehiscence (1154); Cellulitis (1768); Post Operative Wound Infection (2446)
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Event Type
Injury
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Event Description
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Per the clinic, the patient developed a wound infection (cellulitis) at the incision site leading to wound dehiscence and exposure of the receiver/stimulator.There are plans to explant the device; however, this has not occurred as of the date of this report.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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Correction: the correct b4 for mdr folow-up #2 is (b)(6) 2024.
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Event Description
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Per the clinic, it was also reported that the patient underwent attempted revision surgery (date not reported).However, the issue could not be resolved.The device was explanted on (b)(6) 2023.There are plans to reimplant the patient with a new device; however, this has not occurred as of the date of this report.
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Event Description
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Per the clinic, the patient was placed on a 28 days course of topical antibiotics (specific date not reported).
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Event Description
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Per the clinic, it was reported that the patient underwent revision surgery on (b)(6) 2024 under general anaesthetic.
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Search Alerts/Recalls
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