Model Number 0673 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Unspecified Infection (1930); Sepsis (2067)
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Event Date 04/20/2023 |
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 right ventricular (rv) lead was part of a system revision due to infection and abscess at the chest wall.Reportedly, the patient had a septic left knee.There were no additional adverse patient effects reported.The rv lead was explanted.
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Event Description
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It was reported that this right ventricular (rv) lead was part of a system revision due to infection and abscess at the chest wall.Reportedly, the patient had a septic left knee.There were no additional adverse patient effects reported.The rv lead was explanted.
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Manufacturer Narrative
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Upon receipt at our post market quality assurance laboratory, additional information from product investigation indicates that the allegation against the lead was not confirmed.The lead was analyzed, passed all the baseline tests and exhibited normal lead functions.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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