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Model Number 3387S-40 |
Device Problems
Break (1069); Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/18/2015 |
Event Type
Injury
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Manufacturer Narrative
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Analysis of the lead (lot# va0rcv6) found conductors #1, #2, and #3 were broken at the connector weld site due to overstress damage.The proximal segment was severely stretched.The connector sleeve #1 and #2 were pulled out of position and the connector sleeve #3 was pulled off the lead.Unable to determine the root cause of the overstress on the lead.
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Event Description
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It was reported that an incision was made near the lead-extension connection site during the stage 2 procedure and the resident grabbed the lead cap and boot to unscrew the cap.As the cap and boot were grabbed, it was no longer connected to the lead prior to using the torque wrench and had pulled off.The healthcare provider (hcp) noted that three days prior to the report the lead was examined during the ¿second sided¿ procedure and was intact.The cap and boot were opened on the ¿mayo stand¿ to find that the lead was still under the skin.The amount of force used to expel it was typical and the hcp thus audibly gasped at the finding of no lead.An attempt to find the lead was made and a c-arm was brought in to assist.After 30 minutes the lead was eventually found and was completely damaged; there was significant damage across all contacts.The coils protruding from contact 0 and 2 were absent.There was no way to salvage the lead, so the hcp cut the end and brought the patient back in the following day to replace the damaged lead.The entire lead was explanted and replaced with a new one in the same location.The cause of the damage was not determined.There were no patient symptoms and he was alive with no injury at the time of the report.
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Manufacturer Narrative
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Concomitant medical products: product id neu_leadcap_acc, lot# unknown, product type: accessory.(b)(4).Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.
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Manufacturer Narrative
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(b)(4).
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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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