Model Number NEU_STYLET_ACC |
Device Problems
Difficult to Insert (1316); Material Twisted/Bent (2981)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/13/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Continuation of medical devices: product id 977d260, serial# (b)(4), product type screening device.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¿s representative (rep) regarding a trial patient.The rep reported that the straight stylet bent during use in the trial.The physician placed the needle, removed the stylet and placed the stylet again and it hit a hard structure and came out with a slight bend, but not a kink.The rep confirmed that the bent stylet was not used.The rep stated she ¿can¿t say she noticed a difference or saw that its been bent or not¿ and that she ¿had never any complaints¿ about this in the past.The item was disposed of.No further complications were reported.
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Manufacturer Narrative
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Additional information indicated this event has also been reported in mfg report (b)(4).Any additional information regarding the event will be documented in this report.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 from a manufacturer's representative.It was reported that a physician was implanting a trial lead using a straight stylet and then found the stylet to be bent after using it.Additional information was received from the manufacturer's representative.It was clarified that the rep did see that the stylet was slightly bent after the hcp used it.The rep was not sure if it was bent because of the use of it or it was possibly slightly bent already and just packaged/sent that way.Cause is still unsure.Additional information was received from the manufacturer's representative.It was reported that the physician had already entered into the patient's body with one pass of the needle, there was minimal pressure placed on the needle, and surely not enough to bend the stylet.
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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 from the rep who reported that the hcp has experienced multiple cases of stylette looking bent.
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Search Alerts/Recalls
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