B3-date of event is estimated.Additional components potentially involved in the event include: common device name: scs lead, model: 3186, udi: (b)(4), serial:(b)(6), lot: a000113128 common device name: drg: lead, model:mn10450-50a, udi: (b)(4), serial:(b)(6), batch: 9054571 a patient experiencing ineffective stimulation was reported to abbott.Patient had both scs and drg systems explanted due to ineffective pain relief.The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determined.
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