Model Number 6010 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 09/11/2020 |
Event Type
Injury
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Manufacturer Narrative
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The patient declined to provide weight.The results/ method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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It was reported that during the patient's lead removal surgery (related manufacturer reference number: 1627487-2020-31906), the burr hole cover broke apart.The physician was able to remove most of the pieces, however some fragments remain implanted.The procedure was extended by 1 hour.Surgical intervention may take place at a later date to remove the remaining fragments.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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During implantation procedure the remain burr hole cover pieces were removed.
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Search Alerts/Recalls
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