Model Number NEU_ENTERRA_INS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Erythema (1840); Unspecified Infection (1930); Fluid Discharge (2686)
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Event Date 02/21/2017 |
Event Type
Injury
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Manufacturer Narrative
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The main component of the system and other applicable components are: product id: 37800, serial# (b)(4), implanted: (b)(6) 2017, product type: implantable neurostimulator.Product id: 435135, serial# (b)(4), implanted: (b)(6) 2012, product type: lead.Product id: 435135, serial# (b)(4), implanted: (b)(6) 2012, product type: lead.If information is provided in the future, a supplemental report will be issued.
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Event Description
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A healthcare provider reported they suspected a patient had an infection, but culture results have not returned from the lab at the time of the report.They said that shortly after a 2017 revision, the patient feel and their incision opened up.The patient went to the emergency room (er) where they sutured the incision to close it.Shortly after that on (b)(6) 2017 the patient had drainage from the ins site.The hcp removed the ins on (b)(6) 2017 and left the leads in the patient.The ins was replaced on (b)(6) 2017.On (b)(6) 2017 the patient was back in the office with drainage.The ins and leads were removed on (b)(6) 2017.No further complications were reported/anticipated.Please see rr 3004209178-2017-23578.
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Manufacturer Narrative
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Concomitant medical products: product id: 37800, serial (b)(4), implanted: (b)(6) 2017, product type: implantable neurostimulator.Product id: 435135, serial (b)(4), implanted: (b)(6) 2012, product type: lead.Product id: 435135, serial (b)(4), implanted: (b)(6) 2012, product type: lead.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Additional information received from the healthcare professional (hcp) reported that the device was discarded so the affected device was not available.The cause of the infections and drainage was determined to be staphylococcus aureus which was being treated with clindamycin 600 mg for 6 weeks.The patient fell shortly after the replacement on (b)(6) 2017 which opened up the incision site.On (b)(6) 2017, the patient continued to have serious drainage from the incision site.Debridement of skin, muscle and fascia for necrotizing infection with removal of mesh was done on (b)(6) 2017.The leads were preserved in the patient.On (b)(6) 2017, replacement surgery was performed in a new location.Leads were located and cleaned prior to attaching.There was a report that at the time the device was interrogated, programmed and there was no evidence of infection.On (b)(6) 2017, the patient had been doing well since replacement surgery on (b)(6) 2017.They were placed on augmentin for redness and drainage from incision site 1 week prior to office visit.The site continued to have drainage and now had a small opening in the middle of the wound.Surgery was done on (b)(6) 2017 to remove the device and leads due to infection.No further complications were reported/anticipated.
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Manufacturer Narrative
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Product id: 37800, serial# (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2017, product type: implantable neurostimulator; product id: 435135, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2017, product type: lead; product id: 435135, serial# (b)(4), implanted: (b)(6) 2012, explanted: (b)(6) 2017, product type: lead.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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