Model Number 97714 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Abscess (1690); Bacterial Infection (1735); Purulent Discharge (1812); Unspecified Infection (1930)
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Event Type
Injury
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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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Information was received from a manufacturer representative regarding a patient with an implantable neurostimulator (ins) for the treatment of spinal pain.It was reported that the patient had an infection at the ins site.It was noted that the infection was not confirmed.No further complications are 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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Event Description
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Additional information was received from a manufacturer representative (rep).It was reported the patient recovered without sequela and was discharged to a nursing home.The ins was not returned as the customer discarded it after explant.No further compilations were reported.
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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 a manufacturer representative (rep).It was reported the infection was confirmed and was gram negative proteus.The device was explanted on (b)(6) 2018.The infection was not resolved at the time of this report.No further complications were reported.
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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 a manufacturer¿s representative (rep).The rep reported that the patient had not had anything implanted since (b)(6) 2018.The rep reported that there was an abscess/pus over the lumbar incision.The rep reported that the patient stayed in the hospital for a couple of weeks, then a nursing home, then home from (b)(6) 2018.The rep reported that the patient was in for a follow up on (b)(6) 2018 and an abscess was noted over the lumbar incision and then removed.The rep reported that pus was present and was sent for culture.The rep reported that the patient was on antibiotics the whole time.The rep reported that the patient was currently working with a wound vac as well.No further complications were reported.
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Search Alerts/Recalls
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