Model Number G156 |
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 01/23/2023 |
Event Type
Injury
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was explanted due to exhibiting high out of range pacing impedance measurements on the right ventricular channel.During the new implant procedure, a header connection issue was observed with the new lead.Another device was implanted.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Additional information was added to the following fields: b5: describe event or problem field.
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was explanted due to exhibiting high out of range pacing impedance measurements on the right ventricular (rv) channel.Initially only the rv was going to be explanted however, during the new implant procedure, a header connection issue was observed with the new lead, therefore, it was decided to replace the device as well.Another device was implanted instead.No additional adverse patient effects were reported.
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Manufacturer Narrative
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The returned device was inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Dimensional analysis of the header was completed.Each port measured as expected.Pacing and sensing functions were tested and the device was verified to operate as expected.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.Additional information was added to the following fields: b5: describe event or problem field.
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) was explanted due to exhibiting high out of range pacing impedance measurements on the right ventricular (rv) channel.Initially only the rv was going to be explanted however, during the new implant procedure, a header connection issue was observed with the new lead, therefore, it was decided to replace the device as well.Another device was implanted instead.This device was returned to boston scientific for analysis.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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