Model Number 4543 |
Device Problems
High impedance (1291); Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/23/2023 |
Event Type
Injury
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Event Description
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It was reported that this left ventricular (lv) lead had high out of range pacing impedances.This patient was admitted to this hospital for further evaluation.The patient was noted to have had physical strain several months ago, and it is suspected that this physical effort caused lead damage.The lv pacing was subsequently disabled, and device reprogrammed to right ventricular (rv) lead only.No additional adverse patient effects were reported.
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Event Description
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It was reported that this left ventricular (lv) lead had high out of range pacing impedances.This patient was admitted to this hospital for further evaluation.The patient was noted to have had physical strain several months ago, and it is suspected that this physical effort caused lead damage.The lv pacing was subsequently disabled, and device reprogrammed to right ventricular (rv) lead only.No additional adverse patient effects were reported.
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Manufacturer Narrative
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This lead remains implanted and disabled, therefore return is not expected.
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Search Alerts/Recalls
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