Model Number 4543 |
Device Problems
No Apparent Adverse Event (3189); High Capture Threshold (3266)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/12/2022 |
Event Type
Injury
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Event Description
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It was reported that this crt-d emitted tones due to low oor pli on the right ventricular (rv) lead, then several years later the shock lead impedance went from normal values to high, out of range.The pacing impedance also increased but still showed within range pacing impedances.Also, the pacing threshold rose up.With a bit of movement, there was some subtle noise on rv lead pace/sense channel, but not on shock channel.A conductor issue of some kind was considered.The lead is likely to be revised soon.Other reprogramming options were considered, and it was mentioned that some reprogramming changes had already been completed.A commanded shock was not considered as the patient is in end stage renal failure.No falls or other medical changes to account for change either.At this time the rv lead and the left ventricular (lv) lead were explanted.No additional adverse patient effects were reported.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that this crt-d emitted tones due to low oor pli on the right ventricular (rv) lead, then several years later the shock lead impedance went from normal values to high, out of range.The pacing impedance also increased but still showed within range pacing impedances.Also, the pacing threshold rose up.With a bit of movement, there was some subtle noise on rv lead pace/sense channel, but not on shock channel.A conductor issue of some kind was considered.The lead is likely to be revised soon.Other reprogramming options were considered, and it was mentioned that some reprogramming changes had already been completed.A commanded shock was not considered as the patient is in end stage renal failure.According to the field representative, the patient fell of a scooter and fractured his rv lead.The left ventricular (lv) lead already had chronically high thresholds.The patient had access issues due to dialysis so could not have the device/leads revised and/or implanted from the right side.Extraction was ordered and was a difficult case likely further compromising any chance of access on the left side.The entire system with the rv and lv leads was explanted and replaced with a subcutaneous implantable cardioverter defibrillator.Nothing is being returned as all the leads were shredded during extraction and fished out using snares.Device was sent to pathology.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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