Section a4: during processing of this incident, further information regarding weight was requested but not received.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: drg slim tip lead, model: mn10450-50a, udi: (b)(4), serial: (b)(6), batch: (b)(6).
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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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