Model Number 429878 |
Device Problems
Break (1069); Failure to Capture (1081); Retraction Problem (1536); Activation, Positioning or Separation Problem (2906); High Capture Threshold (3266)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/09/2018 |
Event Type
malfunction
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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 the guidewire could not be removed from the left ventricular (lv) lead after placement and then broke off inside the lead.There was high thresholds and no capture after this occurred.The lead was removed and replaced.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the full lead was returned and analyzed.Analysis indicated that the distal conductor of the lead was obstructed due to a stylet/guidewire fragment stuck in the lumen.The stylet/guidewire was broken.The distal conductor was extrinsically distorted due to kinking/buckling.Visual analysis of the lead indicated damage at implant.The analyst noted that visual inspection found the lead conductor distorted, and a piece of guidewire stuck in the lead was observed.The guidewire fragment was removed from the lead.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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Search Alerts/Recalls
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