Model Number 439888 |
Device Problem
Device Contamination with Body Fluid (2317)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/25/2015 |
Event Type
malfunction
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Event Description
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It was reported that during the implant procedure blood was noted on the inner body of the lead for the length of lead.It was also noted that the technician in the procedure flushed the lead prior to first insertion through the sheath.The lead was not used and another lead was successfully implanted.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.Concomitant medical products: dtba1q1, icd, implanted: (b)(6) 2015.(b)(4).
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Manufacturer Narrative
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Product event summary: the full lead was returned in segments, analyzed and no anomalies were found.There was blood on the lv4 (low voltage 4) conductor, but it was not obstructed.There was blood on the lv3 (low voltage 3) conductor, but it was not obstructed.There was blood on the proximal conductor of the lead and it was not obstructed.There was blood on the distal conductor of the lead and it was not obstructed.
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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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