It was initially reported that the patient's generator could be easily moved.At the time of the initial evaluation, the surgeon decided it was not medically necessary to proceed with surgery to address issues with the device migration.A non-absorbable suture was used to secure the generator at the time of the last generator replacement surgery.A subsequent report from the patient on (b)(6) 2016 indicated that she was actually proceeding with surgery.Further information indicated that there issues with seepage from the chest wound and device migration and protrusion.Follow up after her report indicated that her vns system was fully removed on suspicion of infection following a visit to the er and hospital admittance, and she was subsequently released from the hospital.Information received from the explanting surgeon's office confirmed that the patient's system was fully removed.The patient was admitted in-patient on (b)(6) 2016.The generator was reportedly extruding through a dehiscence wound.The generator was removed on a suspected infection in the chest.The lead was also removed to allow for full recovery, although there was no suspicion of infection in the neck.An antibiotic was prescribed.The pathology report for cultures showed negative or negligible for all tests, and showed no growth in culture media.The suture had to be cut for generator removal, indicating it was still intact before explant.No further information was given on potential causes or contributing factors to the device migration, protrusion, or extrusion.The explanting facility does not return explanted products per their internal policy, so return of the removed devices is not expected.The generator device history record was reviewed and found all specifications were met prior to distribution, and the generator was sterilized prior to distribution.
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