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Catalog Number 283907000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Arrhythmia (1721)
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Event Date 02/01/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).A complaint investigation will be performed.The complaint product is not available for the investigation.A supplemental report is not anticipated unless the results of the complaint investigation identify a corrective action or additional relevant information.Should the product become available, a physical evaluation will be conducted and a supplemental report filed with the results.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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(b)(4).It was reported, the surgeon noticed alterations to the cardiac frequency of the patient's subsequently to the use of confidence cements.
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Manufacturer Narrative
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Product complaint # = > (b)(4).Udi: ((b)(4).Device was not returned for evaluation.A review of the device history record for kit and cement were conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.Without the product, we are unable to confirm the reported issue or identify the root cause.A review of the lot history for this kit and its associated cement did not find any issues pertinent to this event.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer and no systemic trends were found, this complaint file will be closed with no further action required.Should more information and/or the sample be provided at a later time, this complaint will be reopened and device evaluated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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