Date of event estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.During processing of this incident, attempts were made to obtain complete patient information.Further information was requested but not received.Additional components potentially involved in the event include: common device name: lead, model: 3186, udi: (b)(4), serial: (b)(4), batch: a000065684.Common device name: anchor, model: 1192, udi: (b)(4), serial: n/a, batch: 6582261.
|
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.
|