Model Number 1258T/86 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/24/2019 |
Event Type
malfunction
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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.Further information was requested but not received.
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Event Description
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It was reported that the patient presented during an initial implant procedure.Upon positioning, the physician noted the insulation of the left ventricular lead was damaged.The physician removed the lead while the chest pocket was open during procedure on (b)(6) 2019.
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Manufacturer Narrative
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A complete lead was returned for analysis in one piece measuring 86.0 cm.Visual examination found a cut to the lead body insulation 10.8 cm from the connector pin.X-ray examination found no anomalies.No conductor fractures or internal shorts were noted.The reported event of insulation damage was confirmed due to procedural damage.
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Search Alerts/Recalls
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