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Model Number 37601 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Injury (2348)
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Event Type
Injury
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Event Description
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It was reported the patient had an infection at the lead location on the left upper side of the patient¿s head.The patient presented at the hospital with an existing small wound on his head and worsened over time; it was noted this wound was revised during a neurostimulator replacement on (b)(6) 2014.Diagnostics and examination were performed on (b)(6) 2014, but results were not provided.Laboratory blood testing was completed on (b)(6) 2015 but were normal, no elevated c-reactive protein (crp).However, a lab culture on (b)(6) 2015 from the extension showed positive for enterococcus faecalis.The patient was hospitalized, treated with antibiotics (floxapen 500mg 3dd on (b)(6) 2015), and eventually it was decided to explant the patient¿s extensions and neurostimulator.Lead 1 was not explanted.It was noted the neurostimulator was explanted out of precaution, the infection was not directly related to the stimulator because there were no problems around the stimulator itself; however, it was unknown if there was really no relatedness to the device.There was no further information provided about lead 2 or the patient¿s two extensions.The patient was waiting for a new system and the event was ongoing.If additional information is received, a follow-up report will be sent.
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Manufacturer Narrative
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Concomitant products: product id 338902836, lot # b0231131k, implanted: (b)(6) 2004, product type lead; product id neu_unknown_lead, serial # unknown, product type lead; product id neu_unknown_ext, serial # unknown, explanted: (b)(6) 2015, product type extension; product id neu_unknown_ext, # serial # unknown, explanted: (b)(6) 2015, product type extension.(b)(4).
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Manufacturer Narrative
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Concomitant medical products: product id: 338902836, lot# b0231131k, implanted: (b)(6) 2004, product type: lead.Product id: ne u_unknown_lead, product type: lead.Product id: 37085-60, serial# (b)(4), explanted: (b)(6) 2015, product type: extension.Product id: neu_unknown_ext, explanted: (b)(6) 2015, product type: extension.Product id: 37085-60, serial# (b)(4), explanted: (b)(6) 2015, product type: extension.Product id: neu_unknown_ext, explanted: (b)(6) 2015, product type: extension.
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Event Description
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Additional information received reported the outcome of the event was resolved without sequelae.
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Search Alerts/Recalls
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