Model Number 6495F |
Device Problems
Break (1069); Unraveled Material (1664)
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Patient Problem
No Information (3190)
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Event Date 09/14/2018 |
Event Type
Injury
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Manufacturer Narrative
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Conclusion: medtronic has received the product and the analysis is in progress.A supplemental report will be submitted upon completion of the analysis.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information that this pacemaker dependent patient had temporary pacing leads implanted following a heart valve implant.On day 2 post operative the temporary pacing lead exhibited loss of capture.It was believed that the lead had "broken" and "unraveled".The patient required adrenaline be administered.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Medtronic received additional information that as a result of the loss of capture, the patients heart rate reduced to 50bpm which subsequently caused a reciprocal drop in his blood pressure.In accordance with this deterioration, the patient was then commenced on an adrenaline infusion and 5 days later discharged with no further complications.Added patient weight to field.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Medtronic received additional information that upon return of these temporary pacing wires to medtronic, it was noted that they are not manufactured by medtronic.No further information is required.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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