Model Number 37612 |
Device Problems
Disconnection (1171); Migration or Expulsion of Device (1395)
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Patient Problems
Wound Dehiscence (1154); Bacterial Infection (1735); Purulent Discharge (1812); Erythema (1840); Burning Sensation (2146); Test Result (2695)
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Event Date 05/30/2018 |
Event Type
Injury
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Manufacturer Narrative
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Information references the main component of the system.Other relevant device(s) are: product id: 3708660, serial/lot #: (b)(4), ubd: (b)(6) 2019, udi#: (b)(4); product id: 3708660, serial/lot #: (b)(4), ubd: (b)(6) 2019, udi#: (b)(4).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 provider about a patient with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the patient's extension and ins site were infected.It was reported that the extension had migrated/dislodged.The infection was stated to be (b)(6).The patient was given antibiotics.A lab test found the white blood cell count to be 8000/ul and c (b)(6) proteins at.39mg/dl.It was reported that the patient's ins and extension were exposed with seropurulent secretion, erythema and local heat.The patient's ins was repositioned to the left subclavicular area and the extensions were explanted and replaced on (b)(6) 2018.The event resulted in in-patient hospitalization and an urgent care visit.The etiology was listed as related to the device/therapy.
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Manufacturer Narrative
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Section d information references the main component of the system and other applicable components are: product id 3708660 serial# (b)(4) implanted: 2016-(b)(6) explanted: 2018-(b)(6) product type extension product id 3708660 serial# (b)(4) implanted: 2016(b)(6)explanted: 2018-(b)(6) product type extension.If information is provided in the future, a supplemental report will be issued.
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Event Description
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No additional information was received.
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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.The patient's gender was updated.No further complications were reported.
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Search Alerts/Recalls
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