Concomitant medical products: product id: 3587a-25, lot#: 0209901683, implanted: (b)(6) 2016, explanted: (b)(6) 2018, product type: lead.Product id: 3587a-25, lot#: 0209536992, implanted: (b)(6) 2016, explanted: (b)(6) 2018, product type: lead.Product id: 3708695, serial#: (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2018, product type: extension.Product id: 3708695, serial#: (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2018, product type: extension.Other relevant device(s) are: product id: 3587a-25, serial/lot #: (b)(4), ubd: 04-dec-2018, udi#: (b)(4); product id: 3587a-25, serial/lot #: (b)(4), ubd: 04-dec-2018, udi#: (b)(4); product id: 3708695, serial/lot #: (b)(4), ubd: 29-oct-2019, udi#: (b)(4); product id: 3708695, serial/lot #: (b)(4), ubd: 29-oct-2019, udi#: (b)(4).D2.Device is being used off label.If information is provided in the future, a supplemental report will be issued.
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Information was received from a healthcare professional (hcp) of a clinical study regarding a patient with an implantable neurostimulator (ins) for neuropathic pain left hemicorpus and face, and cerebral vascular accident/stroke.It was reported that the patient developed an infection around the electrode and ins.Patient examination found superficial blister formation on the ins (pectoral) with red, warm, local light pressure pain.There was fistulation of the wound next to the blister.There were ¿nog¿ systemic signs of an infection.Medications of dalacin, vancomycin-rocephin, and tazocin were administered.The entire system of ins, leads, and extensions were explanted and not replaced.During the explant procedure, the cables (leads and extensions) seemed to be grown in and around the leads; there was scar tissue with some infection.The issue was resolved.In patient hospitalization occurred.Etiology was not related to the device, therapy, or implant procedure.No further complications were reported or anticipated.
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