Model Number NEU_ENS_STIMULATOR |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Cellulitis (1768); Unspecified Infection (1930); Staphylococcus Aureus (2058); Seroma (2069); Meningitis (2389)
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Event Date 03/30/2018 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: neu_unknown_lead, implanted: (b)(6) 2018, 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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Information was received from a healthcare professional of a clinical study reporting that they contacted patient to remind them for their upcoming stimulator trial evaluation appointment and the patient reported that they were in the hospital with an infection.Patient reported that they were diagnosed with bacterial meningitis that went to their brain following trial on (b)(6) 2018.Patient also reported there was fluid in their spine where the lead was positioned.Patient reported that they will be on long-term antibiotics and should present for their appointment on (b)(6) 2018.The event was ongoing.No further complications were reported as a result of this event at this time.
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Manufacturer Narrative
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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 was received from the health care provider (hcp) of a clinical study reporting that the patient developed an methicillin-sensitive staphylococcus aureus (mssa) epidural abscess and meningitis.At the patient¿s post-op evaluation on (b)(6) 2018, the physician removed the trial leads.The patient was discharged home with picc line antibiotics, though mostly asymptomatic.The event resulted in an er visit and inpatient hospitalization.
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Manufacturer Narrative
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Product id: neu_unknown_lead, serial# unknown, implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: lead.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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No new information was reported (the patient's weight was reported).
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Manufacturer Narrative
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Product id: neu_unknown_lead, serial# unknown, implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: lead.Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Product id: 977d260, serial# (b)(4), implanted: (b)(6) 2018, product type: screening device; product id: 977d260, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2018, product type: screening device.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 was received from a healthcare professional (hcp).It was reported that the hospital (b)(6) stated cellulitis with possible abscess around the insertion site and an mri revealed epidural abscess.Additional interventions included administering medications of ancef.The clinical diagnosis was corrected to infection of spinal cord stimulation trial leads.It was noted that the outcome of the event was resolved without sequelae as of (b)(6) 2018.No further complications were reported/anticipated.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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