Additional suspect medical device components involved in the event: model#: sc-2408-56, serial#: (b)(4), description: avista mri perc lead kit, 56cm; model#: sc-4319 lot#: 19653612 description: clik x mri anchor.The explanted devices were not returned to bsn.A review of the manufacturing documentation for the ipg, lead, and anchor revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.A review of the sterilization documentation for the devices was found to be satisfactory.
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