Model Number 3086 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 02/03/2021 |
Event Type
Injury
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Manufacturer Narrative
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During processing of this complaint, attempts were made to obtain complete patient and device information.The unique device identifier (udi #) is unknown because the lot and part number were not provided.
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Event Description
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It was reported that during the trial procedure on (b)(6) 2021, the trial had to be abandoned due to excessive bleeding.A lateral x-ray was taken and saw the lead was shallow and in the subcutaneous space.No products were implanted.The excessive bleeding has since resolved.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the lead was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.
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Search Alerts/Recalls
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