Model Number 3387S-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 11/14/2018 |
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 healthcare provider (hcp) via a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins).It was reported the neurosurgeon opened the lead and noticed the bottom contact was bent and decided not to use that lead.No symptoms or 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 was received from the hcp via the rep clarifying the lead was already defective when they opened the box.
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Manufacturer Narrative
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Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is complete.(b)(4).If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Analysis revealed that the distal end of the lead was bent.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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