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Model Number LSP202V |
Device Problems
Failure to Capture (1081); Under-Sensing (1661); Device Dislodged or Dislocated (2923); Difficult or Delayed Separation (4044)
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Patient Problem
Embolism/Embolus (4438)
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Event Type
Injury
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Event Description
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It was reported that the patient presented for aveir leadless pacemaker (lp) implant.During the procedure, it was found that the right ventricular lp exhibited difficulty in separating from the delivery catheter.The lp was eventually fixed.During post-implant check, it was noted that the device was failing to capture and exhibited signal under-sensing.X-ray revealed the lp had dislodged and traveled outside the intended chamber.The lp was retrieved and replaced.The patient was stable.
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Manufacturer Narrative
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The reported event of dislodgement, failure to capture, under-sensing, and separation problem were not confirmed.The reported event of stretched helix was confirmed.Final analysis found the helix was stretched of specification, consistent with having occurred during implant procedure.No further anomalies were detected.
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Manufacturer Narrative
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The reported event of dislodgement, failure to capture, under-sensing, and separation problem were not confirmed.Final analysis found the helix was stretched of specification, consistent with having occurred during implant procedure.No anomalies were detected.A device history record (dhr) review was performed and all required manufacturing processes and inspections steps were confirmed to be completed per the requirements.The device met specifications prior to leaving abbott manufacturing facilities.
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Search Alerts/Recalls
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