Model Number 3389S-40 |
Device Problems
Shipping Damage or Problem (1570); Material Twisted/Bent (2981)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/14/2019 |
Event Type
malfunction
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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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Event Description
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Information was received by a manufacture representative (rep) regarding an implantable neurostimulator (ins).It was reported the patient underwent a deep brain stimulation (dbs) implantation surgery on (b)(6) 2019.After opening the lead package, the tip of the lead was bent and the lead was replaced with a new lead on the same day.The patient was hospitalized and under observation at the time of the report.The cause of the issue was unknown.No symptoms or complications were reported or anticipated.
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Manufacturer Narrative
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Concomitant medical products: product id: neu_stylet_acc, product type: accessory.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is complete.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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Event Description
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Additional information was received.The patient weight was unknown.No further complications were reported.
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Manufacturer Narrative
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Analysis of the lead showed no anomaly.Analysis of the stylet showed no anomaly.Analysis of stimloc burrhole cover showed no anomaly.Fdm 10, fdr 213, and fdc 4315 are associated with the lead, the stylet, and the stimloc burrhole cover.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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