Model Number 1258T/86 |
Device Problems
Break (1069); High impedance (1291); Low Sensing Threshold (2575)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/18/2019 |
Event Type
Injury
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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 follow-up, insulation damage was noted on the left ventricular (lv) lead.The lv lead was explanted and replaced to resolve the event.The patient was in stable condition.
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Event Description
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Additional information received indicated the insulation damage on the left ventricular lead was due to clavicular crush resulting in increased pacing lead impedance and decreased sensing.The insulation damage was confirmed visually and with diagnostic imaging.
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Search Alerts/Recalls
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