Date of event estimated.The allegation is against [1] of [2] [lead]; 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: lead, model: mn10450-50a, udi:(b)(4), serial: (b)(6), batch: 7717276.
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It was reported that the patient's lead had migrated, which was confirmed via imaging.As a result, the patient was experiencing ineffective therapy.Surgical intervention took place where a right l1 lead was added, due to the patient's significant scar tissue the physician could not replace the t12 lead.Effective stimulation was restored.Investigation was unable to determine which of the leads attributed to the event.
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