Model Number 4672 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Purulent Discharge (1812); Unspecified Infection (1930)
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Event Date 09/01/2021 |
Event Type
Injury
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Event Description
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It was reported that an infection was noted during an attempted lead implant.The attempted ra lead was removed and discarded.The existing device system, including a cardiac resynchronization therapy defibrillator (crt-d), and this left ventricular (lv) lead is expect to be scheduled for explant.The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.No additional adverse patient effects were reported.
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Manufacturer Narrative
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This supplemental report is being submitted as the model/serial of the implantable lead was specified.
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Event Description
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It was reported that an infection was noted during an attempted lead implant.The attempted ra lead was removed and discarded.The existing device system, including a cardiac resynchronization therapy defibrillator (crt-d), and this left ventricular (lv) lead is expect to be scheduled for explant.The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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