Model Number 3660 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Edema (1820); Impaired Healing (2378); Fluid Discharge (2686)
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Event Date 06/19/2019 |
Event Type
Injury
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Manufacturer Narrative
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The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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Related manufacturer reference number: 1627487-2019-09295.It was reported the patient's ipg site wound not healing properly.Follow-up information indicated that the physician opted to explant the ipg and cut the lead tail on (b)(6) 2019, leaving the body of the lead still implanted, due to the patient's wound site being drained multiple times within a week.The patient was given iv antibiotics during the procedure and was later discharged and prescribed oral antibiotics.Surgical intervention may take place at a later date to replace the lead and implant a new ipg.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
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Event Description
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Additional information received indicated the patient underwent surgical intervention on (b)(6) 2019 wherein the body of the lead that remained implanted was explanted and replaced.A new ipg was implanted.Therapy was restored post operatively and wound issue has resolved.
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Search Alerts/Recalls
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