Model Number 37800 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Unspecified Infection (1930)
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Event Date 01/24/2019 |
Event Type
Injury
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Manufacturer Narrative
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Concomitant medical products: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2018; explanted: (b)(6) 2019, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2019, product type: lead.Product id: 4351-35, serial/lot #: (b)(4), ubd: 03-oct-2020, udi#: (b)(4); product id: 4351-35, serial/lot #: (b)(4), ubd: 26-sep-2020, (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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(b)(6) 2019, (b)(6): information was received from a healthcare professional (hcp) via a manufacturer representative regarding a patient with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor issues.It was reported that visualization of the pocket site led to a diagnosis of an infection and histology confirmed it.The patient underwent a successful explant of the infected leads and generator/the entire system was removed and the issue was resolved at the time of the report.It was noted that the patient would be allowed to recover for 2 months and consider re-implant at that time.No further complications were reported/anticipated.
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Manufacturer Narrative
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Product id 4351-35, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2019, product type: lead.Product id 4351-35, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2019, product type: lead.(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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Additional information was received from a healthcare professional (hcp).It was reported that the pocket was seeded, so to prevent intra-abdominal spread, both the leads were removed.The infection was noted to be enterobacter, staph aureus that originated from a j tube.No further complications were reported/anticipated.
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Manufacturer Narrative
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Concomitant medical products: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2019, product type: lead.Product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2019, product type: lead.Analysis results were not available at the time of this report.A follow-up report will be submitted when analysis is completed.If information is provided in the future, a supplemental report will be issued.
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Manufacturer Narrative
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Concomitant medical products: product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2019, product type: lead; product id: 4351-35, serial# (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2019, product type: lead.The implantable neurostimulator (ins) (serial number (b)(4)) and leads (serial numbers (b)(4)) were returned and analysis found no anomalies.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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