Model Number 977A260 |
Device Problems
Break (1069); Difficult to Insert (1316); Blocked Connection (2888)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/22/2017 |
Event Type
Injury
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Manufacturer Narrative
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Analysis of the implantable lead found no anomaly.Analysis of the epidural needle found the spoon of the needle had a sharp edge on the undercut side.Continuation of medical devices: product id neu_epiduralneedle, product type accessory.Product id n eu_epiduralneedle, product type accessory.Product id neu_epiduralneedle.Information references the main component of the system.Other relevant device(s) are: product id: neu_epiduralneedle; product id: neu_epiduralneedle.This report is a correction.Regulatory report 3007566237-2018-00087 captured the initial report.No further regulatory reports will be submitted under report number 3007566237-2018-00087.If additional information is received it will be captured in this regulatory report.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Information was received from a manufacturer representative concerning a lead placement issue.It was reported that during implant, the leads were getting caught in the needles and the physician was unable to pull the lead out of the needle when repositioning.The leads were frayed.It was possible that the physician was twisting the needles too much within the needle.They looked at the lead and one was frayed.The lead was not used.No patient injury or symptoms were reported.The leads were going to be returned for analysis.No further complications were reported/anticipated.Additional information was received reporting that there was no associated ins serial number as the case was aborted and rescheduled with paddle leads.No other leads/inss were implanted at the time.The patient¿s weight at the time of the event was unknown.The leads were returned on (b)(6) 2018 and analysis received them on (b)(6) 2018.No further complications were reported/anticipated.The rep provided the patient¿s identifying information.No further complications were reported or anticipated.
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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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Manufacturer Narrative
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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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