Model Number LNQ11 |
Device Problem
Failure to Interrogate (1332)
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Patient Problem
Bacterial Infection (1735)
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Event Date 09/08/2018 |
Event Type
Injury
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Manufacturer Narrative
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This device was reported as included in the field action.Based on the information received and without the return of the product, it cannot be confirmed that this device performed as described in the field action.It is included in the field action in the abundance of caution.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 the implantable cardiac monitor (icm) patient experienced an infection at the device pocket.It was further reported that the device was unable to be interrogated.The patient received antibiotics and the icm was explanted.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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This device was reported as included in the field action noted but returned product investigation found the device did not perform as described in the field action.The device is no longer included as part of the field action.Product event summary: the device was returned and analyzed.Analysis of the device revealed normal battery depletion.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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