The allegation is against 1 of 2 leads; however, it is unknown which lead(s), therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: ipg, model: mn10450-90a, udi: (b)(4), serial: (b)(6), batch: 7538498.
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Correction: h6 - impact code has been updated.During processing of this complaint, attempts were made to obtain complete patient information.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.
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