Model Number 4677 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/09/2022 |
Event Type
malfunction
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Event Description
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It was reported that this left ventricular (lv) lead was a case of an attempted implant lead damage.While attaching flush adapter to the terminal pin, the pin broke off from the lead body.The lead was never implanted, and a new lead was used.No 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.Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Detailed analysis indicated that the allegation was confirmed based on the observation of a broken terminal end.It appears that the lead experienced a force on it in this area greater than the lead was built to withstand.
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Event Description
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It was reported that this left ventricular (lv) lead was a case of an attempted implant lead damage.While attaching flush adapter to the terminal pin, the pin broke off from the lead body.The lead was never implanted, and a new lead was used.No adverse patient effects were reported.
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Search Alerts/Recalls
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