Additional suspect medical device components involved in the event: model: sc-2366-50, serial/ lot: (b)(4), description: linear 3-6 lead 50 cm.Model: sc-2366-50, serial/ lot: (b)(4), description: linear 3-6 lead 50 cm.Model: sc-9218-15, serial/ lot: (b)(4), description: precision m8 adapter 15cm.Model: sc-9218-15, serial/ lot: (b)(4), description: precision m8 adapter 15cm.
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It was reported that the patient experienced an infection at the ipg site.The physician assessed that the infection had traveled to the leads.The patient had symptoms of a fever, a migraine, and there was oozing at the incision and ipg site.The cause of the infection was unknown.A culture was performed, but the results were not provided by the facility.The patient was treated with an antibiotic, cephalexin.The patient underwent an revision procedure and the entire system was explanted due to the infection.A non-boston scientific product that was connected to the ipg was also explanted.All explanted products were discarded by the facility.The patient is doing well postoperatively.
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