Model Number 0175 |
Device Problems
Difficult to Remove (1528); Material Integrity Problem (2978)
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Patient Problems
Hemorrhage/Bleeding (1888); Perforation of Vessels (2135); Foreign Body In Patient (2687)
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Event Date 03/26/2024 |
Event Type
Injury
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Event Description
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It was reported that during an attempted left ventricular lead extraction procedure this right ventricular lead was surgically abandoned as it got damaged and could not be removed, it was cut, and part remains in the body.It was noted that the subclavian was damaged and bleeding was stopped by the physician.It is unknown if a new system will be implanted.This lead is not expected to be returned for analysis.No additional adverse patient effects were noted.
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Event Description
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It was reported that during an attempted left ventricular lead extraction procedure this right ventricular lead was surgically abandoned as it got damaged and could not be removed, it was cut, and part remains in the body.It was noted that the subclavian was damaged and bleeding was stopped by the physician.It is unknown if a new system will be implanted.This lead is not expected to be returned for analysis.No additional adverse patient effects were noted.
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Manufacturer Narrative
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Upon receipt at our post market quality assurance laboratory, the lead was thoroughly analyzed.Visual inspection confirmed that the lead was returned in five segments severed approximately 140mm from the terminal end.Visual inspection of the lead confirmed surface abrasion approximately 110 from the terminal end, insulation abrasion worn through to inner insulation approximately 135mm from terminal end, calcium deposits were also noted on outer insulation.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinical observations.
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Search Alerts/Recalls
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