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Model Number LSP112V |
Device Problems
Capturing Problem (2891); Device Dislodged or Dislocated (2923); Difficult or Delayed Separation (4044)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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Related manufacturer reference number: 2017865-2024-37174.It was reported aveir leadless pacemakers (lp) were used as part of a study involving aveir and micra leadless pacemakers.This event it to report the observations on the aveir lps used in the study.The study reviewed twenty-five consecutive patients who received aveir lps between (b)(6) 2022 from implant to ten weeks post-implant.During one implant attempt, the aveir lp had difficulty releasing from the delivery catheter which resulted in dislodgement and increased capture thresholds.The aveir lp was successfully retrieved and repositioned.The study discussed the safety of aveir lps, referencing the aveir vr trials.The reference cited pericardial effusion and cardiac tamponade were the commonest complications with an incidence between (b)(4).Some of these patients needed sternotomy and 1 patient died in these trials.Vascular access complications, pericarditis, stroke, pulmonary embolism, and contrast nephropathy have been reported with incidence <(b)(4) and device dislodgement with reimplantation happened in (b)(4) of implants in these trials.The study stated, of these complications, only the one case of dislodgement occurred within the twenty-five implants of the study but was hesitant to draw any inferences on safety due to the difference in sample size and short term follow-up limits.The study concluded that aveir lps were similar in effectiveness and safety compared to micra.
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Manufacturer Narrative
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Section e: wiley title: a comparative study of the two leadless pacemakers in clinical practice.(j cardiovasc electrophysiol.2023;34:1896-1903.Doi:10.1111/jce.16019).Authors: ghanshyam shantha md, mph; jonathan brock md; matthew j.Singleton md, mbe, mhs, msc; alexander joseph schmitt md; patrick kozak md; george bodziock md; natalie bradford md; patrick whalen md; prashant bhave md.
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Search Alerts/Recalls
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