Model Number L331 |
Device Problems
Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 07/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.
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Event Description
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It was reported that this pacemaker was part of system revision due to infection.As of this time, the device remains in service.No additional adverse patient effects were reported.
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Manufacturer Narrative
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As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.This supplemental report is being filed to correct the describe event or problem and explant date.
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Event Description
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It was reported that this pacemaker was part of system revision due to infection.As of this time, the device remains in service.No additional adverse patient effects were reported.It was reported that this pacemaker was part of a system revision due to possible infection.There were no additional adverse patient effects were reported.The pacemaker was explanted.
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Search Alerts/Recalls
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