Date of event estimated.During processing of this incident, attempts were made to obtain complete device information.Further information was requested but not received.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 event could not be conclusively determined.The allegation is against 1 of 2 anchor; however, it is unknown which anchor(s), therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: anchor, model: 1194ans, udi: (b)(4), serial: n/a, batch: 6192367.
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Related manufacturer reference number: 1627487-2023-05904.It was reported that the patient was experiencing discomfort at the ipg and anchor site.Surgical intervention took place where the ipg and anchor were explanted and replaced to address the issue.Effective stimulation was restored.Investigation was unable to determine which of the anchors attributed to the event.The allegation is against 1 of 2 anchor; however, it is unknown which anchor(s), therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: anchor, model: 1194ans, udi: (b)(4), serial: n/a, batch: 6192367.
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