Model Number 4351-35 |
Device Problems
Peeled/Delaminated (1454); Shipping Damage or Problem (1570)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/01/2018 |
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 from a manufacturer representative (rep) regarding a patient who was being implanted with a neurostimulator for gastric stimulation.It was reported that the blue prolene separated on the lead.The lead was never implanted and a new lead was used.This issue was noted to be resolved.No symptoms or 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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Event Description
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Additional information received from a healthcare professional (hcp) via a manufacturer representative (rep).It was reported that they were unsure of the cause of the prolene separating.The surgeon believed it was a manufacturing issue.
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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 when analysis is completed.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Analysis of the lead (b)(4) found that the lead was broken at the distal end.The device was subjected to a series of standard tests, including visual inspection and electrical testing.It was found that the hole drilled for the polypropylene suture was off center and out of specification.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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