Related manufacturer reference number: 2017865-2022-06670.It was reported that a patient experienced erythema around the pacemaker pocket and wound dehiscence of the surgical site 15 days after being implanted with a new pacemaker in (b)(6) 2018.The patient underwent antibiotic regimens for a year and a half, with the patient's pacemaker being explanted, replaced and treated with antibiotics on (b)(6) 2020.The new pacemaker later exteriorized one month after this, prompting this pacemaker to also be explanted and replaced.Dermal tests identified that the patient's body was rejecting the nickel in the pacemakers.
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