Model Number 0295 |
Device Problems
Signal Artifact/Noise (1036); Failure to Capture (1081); Fracture (1260); Pacing Problem (1439); Under-Sensing (1661); Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/28/2024 |
Event Type
Injury
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Manufacturer Narrative
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If pertinent information is provided in the future, a supplemental report will be submitted.
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Event Description
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It was reported that after a routine follow up, this right ventricular (rv) lead exhibited loss of capture (loc), noise, undersensing and impaired pacing and sensing.It was noted this rv lead was fractured.Ultimately, this rv lead and device were explanted and replaced with a new system.No additional adverse patient effects were reported.
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Manufacturer Narrative
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The returned lead was analyzed.Visual inspection of the lead noted both the internal and the external insulation was abraded through to the conductor coil.Microscopic evaluation indicated that the insulation damage was caused by localized compressive stress on the insulation surface.Due to the location and the type of damage exhibited, it was concluded that the damage was caused by lead entrapment in the clavicle/first-rib region.
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Event Description
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It was reported that after a routine follow up, this right ventricular (rv) lead exhibited loss of capture (loc), noise, undersensing and impaired pacing and sensing.It was noted this rv lead was fractured.Ultimately, this rv lead and device were explanted and replaced with a new system.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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