Model Number 4351-35 |
Device Problems
Break (1069); Material Deformation (2976)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/16/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Analysis results were not available at the time of this report.An additional report will be sent once analysis is complete.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 healthcare professional (hcp) regarding a patient who was implanted with a neurostimulator for gastric stimulation.It was reported that the needle, attached to the blue polypropylene, bent enough to be unusable.The lead was never implanted and a back-up lead was used.All went well and the patient was fine.No symptoms or further complications were reported or anticipated.
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Manufacturer Narrative
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Analysis of the lead ((b)(4)) found no anomalies.The lead passed all testing.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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