Related manufacturer reference number: 1627487-2024-07769.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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Date of event is estimated.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be 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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