Model Number 7842 |
Device Problems
Failure to Capture (1081); High impedance (1291); Mechanical Problem (1384); Off-Label Use (1494); Failure to Read Input Signal (1581); Positioning Problem (3009); High Capture Threshold (3266)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/06/2024 |
Event Type
malfunction
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Event Description
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It was reported that this lead was an attempted implant into the left bundle branch position in the right ventricular (rv) septum, which is considered off label use.The following clinical observations were observed; difficulty in positioning, unable to obtain good morphology, pace impedance measurements of greater than 2000 ohms, high threshold measurement and non capture at 5 volts.The helix was extended and captured at 10 volts however were unable to get impedance lower after attempting to extend the helix further.The helix was retracted and removed from body.It was confirmed via fluoroscopy that the helix was fully extended.A different lead was attempted which experienced the same outcome.A third lead was then attempted which was successfully implanted.No adverse patient effects were reported.
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Manufacturer Narrative
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This lead is expected to be returned and analyzed.A supplemental report will be filed upon completion.
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Manufacturer Narrative
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Correction to removing code 2699.
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Event Description
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It was reported that this lead was an attempted implant into the left bundle branch position in the right ventricular (rv) septum, which is considered off label use.The following clinical observations were observed; difficulty in positioning, unable to obtain good morphology, pace impedance measurements of greater than 2000 ohms, high threshold measurement and non capture at 5 volts.The helix was extended and captured at 10 volts however were unable to get impedance lower after attempting to extend the helix further.The helix was retracted and removed from body.It was confirmed via fluoroscopy that the helix was fully extended.A different lead was attempted which experienced the same outcome.A third lead was then attempted which was successfully implanted.No adverse patient effects were reported.
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Search Alerts/Recalls
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