Model Number 5086MRI58 |
Device Problem
Kinked (1339)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/07/2014 |
Event Type
malfunction
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Event Description
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It was reported that during an attempted implant, the physician was unable to insert the right ventricular (rv) lead smoothly into the rv.Upon pulling the lead out, it was noted the rv lead was badly kinked and was unusable at that point.The rv lead was removed and replaced successfully.No patient complications have been 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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Product event summary: the full lead was returned, analyzed and the inner insulation of the lead was extrinsically distorted and breached due to pulling/stretching/overstress.The distal and proximal conductor of the lead became extrinsically distorted due to pull ing/stretching/overstress.The overlay tubing of the lead was extrinsically breached due to pulling/stretching/overstress.The outer insulation of the lead became extrinsically distorted due to pulling/stretching/overstress.Visual summary analysis of the lead ind icated damage at implant and stretching.The analyst noted that the lead returned stretched form original length of 58cm to 70cm.
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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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