Model Number 3387S-40 |
Device Problems
Contamination (1120); Unintended Collision (1429); Device Damaged by Another Device (2915)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/14/2017 |
Event Type
malfunction
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Manufacturer Narrative
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A good faith effort will be made to obtain the applicable information relevant to the 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 consumer via a manufacturer representative (rep) regarding a patient with an implanted neurostimulator (ins).The rep reported that during the stage 2 implant, the lead got stuck in the lead end cap, and somehow, made it past the setscrew block and got stuck in the rubber/plastic behind the setscrew block at the tip.The rep reported that the healthcare provider (hcp) tried to dissect the end cap to get the lead, but dropped the contact.The hcp reported that the patient needs constant future mris and so they didn't want to continue using the lead which might have been compromised.The consumer reported that the patient normally falls on the right side.The rep reported that the hcp implanted the left lead, but pulled the right lead.No patient symptoms were reported.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Concomitant medical products: product id 37603, serial# (b)(4), implanted: (b)(6) 2017, product type: implantable neurostimulator.
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Event Description
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The lead lot number was updated.The patient's weight remained unknown.The lead was removed and no hardware was left in on the right side.The surgeon and parent believed that the child may have had a fall after stage 1 and before stage 2 that could have caused the contact to get lodged into the lead end cap.
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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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