Model Number CDHFA500Q |
Device Problems
High impedance (1291); Connection Problem (2900)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/04/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The reported event of header anomaly could not be confirmed.Visual inspection, telemetry, impedance, sensing, pacing and output functions of the device were normal with no anomalies found.
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Event Description
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Related manufacturer reference numbers: 2017865-2023-18226.It was reported that the patient presented in clinic for generator change.During procedure on 4 apr 2023, it was found that a competitive right ventricular lead was unable to be inserted fully into the implantable cardioverter defibrillator (icd) header.The icd was not implanted and a replacement near at hand was used.The replacement icd also exhibited the same issue.The replacement icd was not implanted as well, and the original implanted icd was re-implanted to complete the procedure.Patient condition was stable.
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Event Description
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It was also noted that during the procedure, both the pacing and defibrillation impedance were found high and out-of-range for the two replacement implantable cardioverter defibrillators.
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Event Description
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Related manufacturer reference numbers: 2017865-2023-18226.Related manufacturer reference numbers: 2017865-2023-19573.New information received notes that the original replacement of implantable cardioverter defibrillator was due to patient discomfort.
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Search Alerts/Recalls
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