Model Number DB-1216 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Pocket Erosion (2013)
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Event Date 03/24/2023 |
Event Type
Injury
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Manufacturer Narrative
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Additional suspect medical device component involved in the event: product family: dbs-extension.Upn: m365db3128550.Model: db-3128-55.Serial: (b)(6).Batch: 5001508.
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Event Description
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It was reported that two months post-implant procedure the deep brain stimulation (dbs) patient developed a wound infection at their implantable pulse generator (ipg) pocket site.The patient's wound was washed out and they were administered intravenous (iv) and oral antibiotics, however, the reported issue persisted.The patient underwent an explant procedure where the ipg and extension were explanted.The patient is doing well post-operatively.The devices were discarded and will not be returned for analysis.
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Event Description
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It was reported that two months post-implant procedure the deep brain stimulation (dbs) patient developed a wound infection at their implantable pulse generator (ipg) pocket site.The patient's wound was washed out and they were administered intravenous (iv) and oral antibiotics, however, the reported issue persisted.The patient underwent an explant procedure where the ipg and extension were explanted.The patient is doing well post-operatively.The devices were discarded and will not be returned for analysis.Additional information was received that the patient had been readmitted to the hospital for the wound washout and was on antibiotics for three months.A culture revealed the patient had staphylococcus aureus.
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Manufacturer Narrative
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Additional suspect medical device component involved in the event: product family: dbs-extension.Upn: m365db3128550.Model: db-3128-55.Serial: (b)(6).Batch: 5001508.
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Search Alerts/Recalls
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