Date of event: approximated based on the date the manufacturer became aware of the event.Additional suspect medical device components involved in the event: product family: scs-linear leads, upn: (b)(4), model: sc-2218-50, serial: (b)(4), batch: 7081363/ 7081397.
|
It was reported that the patient had difficulty charging the ipg due to the swelling, skin irritation and redness at the ipg and lead incision sites.A computerized tomography (ct) scan was taken and revealed that the patient was diagnosed with cellulitis.It was also reported that the patient had blisters and topical dermatitis from the bandage at the lead incision site.The patient was sent to the emergency room and the patient was prescribed with antibiotics, valium and antarax.All device components were explanted and were discarded.
|