Model Number 1000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Wound Dehiscence (1154); Post Operative Wound Infection (2446); No Information (3190)
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Event Date 12/08/2020 |
Event Type
Injury
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Event Description
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It was reported the patient was scheduled for wound revision surgery.The cause for the surgery was not reported.Device history record was reviewed for both the generator and lead.Both devices were sterilized prior to distribution, and no unresolved nonconformances were identified prior to distribution.No additional relevant information has been received to date.No known surgical intervention has occurred to date.
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Event Description
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Per the physician, the patient was experiencing wound deheisence.It was noted that while removing the patient's shirt, a band-aid was inadvertently peeled off over the incision/skin glue.It was noted the patient had ripped his wound dressing the second day after the surgery.The band-aids were used to cover the incision to prevent the patient from touching the incision.The physician noted that wound picking and suboptimal wound care with band-aids may have led to the premature removal of the skin glue resulting in wound deheisence.The area of wound dehiscence (-1cm) was carefully inspected and visible subcutaneous stitches were noted, but no visibly exposed hardware.The electrode could be palpated under this location.To improve healing of the site and minimize risks of infection, the decision was made to reposition the electrode and revise the wound without underlying hardware.No additional relevant information has been received to date.
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Manufacturer Narrative
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H3.Device evaluated by mfr?, code 81, device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
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Event Description
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Patient had a generator explant.Leads were left implanted.It was stated the wound exploration surgery was due to infection.Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device.No additional relevant information has been received to date.
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Search Alerts/Recalls
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