Model Number SONATA |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Meningitis (2389)
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Event Date 08/27/2020 |
Event Type
Injury
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Manufacturer Narrative
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The device has been explanted and should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
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Event Description
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The user went to the hospital with a high fever and was diagnosed with meningitis.The surgeon found cerebrospinal fluid leakage on the left side, which required repair and treatment.The user has been explanted.
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Event Description
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On (b)(6) 2020 the recipient went to hospital with a high fever caused by an acute upper respiratory infection and was subsequently diagnosed with suppurative meningitis.The surgeon found cerebrospinal fluid leakage (csf) on the left side, which was found before explantation and required repair and treatment.The recipient has been explanted on the left side on (b)(6) 2020 and will be re-implanted in about half a year.As per new information received on 05-nov-2020, the recipient has recovered well and is symptom-free (no fever).
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Manufacturer Narrative
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Conclusion: according to the received information from the field, the recipient was diagnosed with suppurative meningitis.Reportedly the recipient had an upper respiratory tract infection, which was very likely the initiating factor for developing meningitis.Furthermore, the recipient has an incomplete partition type i (ip-1) which makes the recipient more prone to meningitis.The lack of vaccination and the observed csf leakage are also additional contributory factors to the reported event.Device investigation did not reveal any device defect or malfunction.A review of the device's sterilization records shows that the device has been subject to a valid sterilization process.No information available points to the implant being the source of the infection.The recipient was explanted and reportedly recovered totally from meningitis.This is a final report.
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Search Alerts/Recalls
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