Model Number DB-1140 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Irritation (1941); Skin Inflammation/ Irritation (4545)
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Event Date 10/01/2018 |
Event Type
Injury
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Manufacturer Narrative
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It is indicated that the device will not be returned for evaluation as it remains implanted in the patient therefore a failure analysis of the complaint device could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.
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Event Description
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A report was received that the patient developed scar irritation and pulling of scar tissue.The patient was admitted and underwent a revision procedure of the ipg, and nothing was implanted or explanted.The event resolved and the patient was discharged.The event was assessed as possibly device and procedure related and unlikely related to the stimulation.The patient was discharged and the event resolved.
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Event Description
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A report was received that the patient developed scar irritation and pulling of scar tissue.The patient was admitted and underwent a revision procedure of the ipg, and nothing was implanted or explanted.The event resolved and the patient was discharged.The event was assessed as possibly device and procedure related and unlikely related to the stimulation.The patient was discharged and the event resolved.
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Manufacturer Narrative
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Update to box d6a implant date.
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Manufacturer Narrative
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Update to box h6 conclusion code.
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Event Description
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A report was received that the patient developed scar irritation and pulling of scar tissue.The patient was admitted and underwent a revision procedure of the ipg, and nothing was implanted or explanted.The event resolved and the patient was discharged.The event was assessed as possibly device and procedure related and unlikely related to the stimulation.The patient was discharged and the event resolved.
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Event Description
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A report was received that the patient developed scar irritation and pulling of scar tissue.The patient was admitted and underwent a revision procedure of the ipg, and nothing was implanted or explanted.The event resolved and the patient was discharged.The event was assessed as possibly device and procedure related and unlikely related to the stimulation.The patient was discharged and the event resolved.
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Manufacturer Narrative
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Update to box d6a implant date.
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Search Alerts/Recalls
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