Model Number 429888 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/06/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Product event summary the full lead was returned and analyzed.No anomalies were found.The analyst noted that the guidewire was not returned with the lead.Guidewire insertion test was performed using medtronic attain hybrid guidewire, it passed through the lead coil lumen without obstruction.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.
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Event Description
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It was reported that during the left ventricular (lv) lead implant procedure, the lead became sticky after use of two different competitor guide wires.The lv lead was removed and replaced with a different lv lead.Upon use of the new lv lead there was no viable thresholds.The lv lead was removed and a different lead was used to complete the procedure.No patient complications have been reported as a result of this event.
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Search Alerts/Recalls
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