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Model Number MN10450-50A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cerebrospinal Fluid Leakage (1772); Headache (1880)
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Event Date 08/15/2023 |
Event Type
Injury
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Manufacturer Narrative
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The allegation is against 1 of 2 leads; however, it is unknown which lead, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: drg slim tip lead, model: mn10450-50a, udi: (b)(4), serial: (b)(6), batch: 9054571.
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Event Description
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It was reported that during a drg implant procedure a csf leak occurred when placing one of the leads.As a result the procedure was not completed the implanted lead was removed.The patient reported a headache and was to follow up with their physician.Follow up indicated the headache resolved.The allegation is against 1 of 2 leads; however, it is unknown which lead, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: drg slim tip lead, model: mn10450-50a, udi: (b)(4), serial: (b)(6), batch: 9054571.
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Manufacturer Narrative
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The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determine.
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Search Alerts/Recalls
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