Date of event is estimated.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.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: lead, model: mn10450-50a, udi: (b)(4), serial: (b)(6), batch: 9193145.
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Related manufacturer reference number: 1627487-2024-07770.It was reported that the patient was experiencing implant pain at the ipg pocket site.It was additionally reported that the patient was experiencing ineffective stimulation.As a result, surgical intervention took place on (b)(6) 2024 wherein, the ipg was removed from the existing pocket, and placed back into a new pocket to address the issue.Additional leads were added to the system to address the issue of the ineffective stimulation.It is unknown which lead is liable.
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