Model Number 408719 |
Device Problems
High impedance (1291); Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/26/2022 |
Event Type
malfunction
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Event Description
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After an implantation period of approximately 44 months it was reported that an unspecified failure was observed for the lead.The patient was hospitalized and a new lead was implanted.Should additional information be received, this file will be updated.
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Manufacturer Narrative
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The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.
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Manufacturer Narrative
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It was reported that the failure occurred due to mechanical friction of the ra and lv leads.The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.
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Search Alerts/Recalls
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