Model Number 5086MRI45 |
Device Problem
Kinked (1339)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/08/2014 |
Event Type
malfunction
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Manufacturer Narrative
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Product event summary: the full lead was returned, analyzed and the inner insulation of the lead was extrinsically breached due to pulling/stretching/overstress.The proximal conductor of the lead became extrinsically distorted due to kinking/ buckling and the visual summary analysis of the lead indicated damage at implant.
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Event Description
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It was reported that the physician had difficulty trying to advance the lead into a venous sheath and that they felt the insulation "crimping" about 10 centimeters from the tip of the lead.The lead body was pulled near the area of the issue and the insulation straightened out.The lead was not implanted.No patient complications were reported as a result of this event.
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Manufacturer Narrative
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The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.(b)(4).
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Manufacturer Narrative
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Corrected information: no eval explain code.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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