Model Number D153 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Swelling/ Edema (4577)
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Event Date 04/05/2023 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that this implantable cardioverter defibrillator (icd) was part of a system revision due to infection.There were no additional adverse patient effects reported.The icd was explanted.
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Manufacturer Narrative
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This supplemental is being filed to update h6: patient codes with swelling.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that this implantable cardioverter defibrillator (icd) was part of a system revision due to infection.There were no additional adverse patient effects reported.The icd was explanted.
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Search Alerts/Recalls
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