Model Number CD3369-40Q |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
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Patient Problem
Unspecified Infection (1930)
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Event Date 03/01/2024 |
Event Type
Injury
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Manufacturer Narrative
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Further information was requested but not received.A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.Review of the sterilization records confirmed normal sterilization cycles for the products.The cause of infection could not be determined.
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Event Description
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Related manufacturer reference number: (b)(4) it was reported that the patient presented for a follow-up in clinic with an unspecified infection.The physician explanted the system- implantable cardioverter defibrillator (icd), right atrial lead, right ventricle lead and left ventricle lead.The patient was in stable condition throughout the procedure.
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Manufacturer Narrative
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Correction: upon review the implantable cardioverter defibrillator (icd), manufacturer report 2017865-2024-35538, should not have been submitted as a medical device report (mdr) as infection that is not related to the implant site or implanted device is a non-reportable complaint, as the infection occurred as the result of another factor or source.
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Search Alerts/Recalls
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